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Choose a condition to see what trials are open for enrollment

• Wet Age-Related Macular Degeneration (wAMD)

• Geographic Atrophy

• Diabetic Retinopathy

• Diabetic Macular Edema

• Macular Telangiectasia (MacTel)

Wet Age-Related Macular Degeneration Clinical Trials

• ACHIEVE

  ACHIEVE Clinical Trial

  ACHIEVE is a research study evaluating a new treatment approach for people with wet age-related macular degeneration (AMD), also called neovascular AMD (nAMD). This condition happens when abnormal blood vessels grow under the retina and leak fluid or blood, which can damage vision over time.

  Why This Study Is Being Done

  Current treatments for wet AMD often require frequent eye injections to help control disease progression. While these treatments can be very effective, the travel burden and cost of each treatment can be difficult for many patients. The ACHIEVE study is testing whether a new treatment strategy may help control abnormal blood vessel growth, maintain or improve vision and ideally reduce how often patients need injections- making treatment easier and more sustainable for patients.

  Who May Be a Good Candidate

  You may qualify for the ACHIEVE Clinical Trial if you:

  • Have been clinically diagnosed with wet age-related macular degeneration and have choroidal neovascularization (CNV), which means abnormal blood vessels are growing under the retina
  • Are currently receiving or may need treatment with anti-VEGF eye injections
  • Meet certain vision and eye health requirements determined by the study doctor (also listed below)

  Inclusion Criteria

  • Diagnosis: Choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (nAMD)
  • Age: 50 or Older
  • BCVA in Study Eye: ~ 20/32 – 20/160
  • BCVA in Fellow Eye: ~ 20/200
  • Pseudophakic (at least 12 weeks post cataract surgery)
  • CNV lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm^2)
  • Pre-treated wet-AMD: Must have received at least two intravitreal anti-VEGF injections in the past 6 months prior to starting the trial, and have been responsive to the treatment

  Interested in Learning More?

  If you or a loved one has been diagnosed with wet AMD, you may be eligible to participate. Speak with your CRA retina specialist at your next appointment to learn more about whether ACHIEVE or another clinical trial may be right for you.

  Trial Overview

  • Status: Enrolling
  • Sponsor: ABBVIE
  • Phase: 2b
  • Condition: Wet Age-Related Macular Degeneration (wAMD)
  • Duration: 5 years
  • Location: Colorado Retina Associates, Lakewood, CO

• AMGEN 20250115

  Wet Age-Related Macular Degeneration Clinical Trial: AMGEN 20250115

  Sponsor: Amgen Inc.

  Colorado Retina Associates is participating in a clinical study evaluating a treatment for wet age-related macular degeneration (wAMD), a condition where abnormal blood vessels grow in the retina and can cause vision loss.

  This study compares two treatments:

  1. The study medication called ABP 938 (similar to the commonly used drug, Eylea®)
  2. Eylea HD®, the standard, FDA-approved treatment used in our clinic today to treat AMD

  👉 Both medications work by blocking a protein called VEGF, which helps reduce fluid and abnormal blood vessel growth in the eye.

  What to expect

  • Treatment is given as recurring eye injections in a Colorado Retina clinic, every 4 weeks
  • You will receive one of the two treatments (assigned randomly): the study drug- ABP 938 or Eylea HD® (standard of care). Regardless you will receive treatment to manage your AMD
  • Initial injections are given once a month for 3-4 months, then you will be evaluated after to see if you continue to meet study criteria and require additional monthly injections.
  • Total study duration is 3-6 months
  • Your vision and eye health will be closely monitored throughout

  You may be eligible if you:

  • Are 50 years or older
  • Have been recently diagnosed with wet AMD
  • Study Eye BCVA: 20/32 – 20/320 andin the Fellow Eye BCVA: Better than counting fingers. Ii.e., your vision in the affected eye must be within a certain range to ensure the study includes patients who can still benefit from treatment
    Active, treatment-naïve subfoveal CNV due to wet AMD
  • AMD is untreated (no prior injections in the study eye)
  • Subfoveal choroidal neovascularization (CNV) due to wet AMD. Meaning, the abnormal blood vessels are located in the center of the retina
  • Have active fluid or swelling in the retina

  You may not be eligible if you have:

  • Significant scarring or damage in the center of the retina
  • Prior major eye surgery or retinal detachment in the study eye
  • Other vascular retinal conditions: diabetic retinopathy, diabetic macular edema, uveitis, etc.
  • Certain uncontrolled medical conditions, such as, high blood pressure (160/95 or higher), history of heart attack or cardiac disease, cancer, stroke, kidney disease

  Why consider participating?

  • Access to a treatment similar to a leading therapy
  • Free treatment, with potential stipends
  • Close monitoring and holistic care by your expert CRA retina specialists
  • Help advance future treatment options for wet AMD

  Key Takeaway: This is a short-term (3 to 6-month), head-to-head study comparing two similar treatments for newly diagnosed wet AMD to confirm they work equally well and safely.

  Trial Overview

  • Sponsor: AMGEN Inc.
  • Condition: Wet Age-Related Macular Degeneration (wAMD)
  • Duration: 3-6 months
  • Location: Colorado Retina Associates, Lakewood, CO

• AQUARIUS

  Wet Age-Related Macular Degeneration Clinical Trial: AQUARIUS

  This FDA-backed clinical study is evaluating a gene therapy (Ixo-vec) for wet age-related macular degeneration (wAMD). The goal is to determine if a one-time injection can provide long-term control of the disease, potentially reducing or eliminating the need for frequent anti-VEGF injections (like Eylea®). Ideally the trial shows participants receiving Ixo-vec maintain vision and control fluid with fewer injections over time.

  How this different from standard treatment

  • Standard care: Injections every 4–8 weeks
  • Study approach: One group receives a single gene therapy injection designed to continuously produce medication in the eye
  • The other group receives standard Eylea injections every 8 weeks

  Eligibility Criteria:

  • 50 years or older
  • Have wet AMD (new or previously treated)
  • Have vision in a specific range (~20/32 to 20/200)
  • Show improvement with initial treatment (fluid reduction on imaging)

  Exclusion Criteria:

  • Prior gene therapy
  • Significant scarring or damage in the center of the retina
  • History of retinal detachment
  • History of uveitis or ocular inflammation condition
  • Recent steroid injections (within 6 months)
  • Recent stroke or heart attack (within 6 months)
  • Certain cancers within the past 5 years

  Treatment & Study Commitment

  • Initial visits and screening required
  • All patients receive standard Eylea at the start
    Patients are randomly put into two groups:

  1. Gene therapy group: One-time injection at Week 1
  2. Control group: Ongoing injections every 8 weeks

  • Use of steroid eye drops for several months
  • Regular follow-up visits for ~1 year

  Key Patient Benefits

  • Access to a potentially long-lasting treatment
  • May significantly reduce injection burden
  • Complimentary treatment, potential stipends and transportation benefits, and other monetary perks
  • Close monitoring by retina specialists
  • Contribute to advancing future AMD treatments

  Key Clinical Insight for Providers

  • Mechanism: Intravitreal gene therapy (Ixo-vec) → sustained intraocular aflibercept production (“biofactory approach”)
  • Includes both treatment-naïve and previously treated patients
  • Requires demonstrated early treatment response (fluid reduction)

  Washout Requirements:

  • Anti-VEGF: 28 days
  • Steroids: 6 months

  Trial Overview

  • Sponsor: Adverum Biotechnologies, Inc.
  • Phase: 3 | Design: Randomized, Double-Masked
  • Condition: Wet Age-Related Macular Degeneration (wAMD)
  • Duration: ~1 year
  • Location: Colorado Retina Associates, Lakewood, CO

Enrolling Geographic Atrophy Clinical Trials

• GALLOP

  GALLOP Clinical Trial

  Sponsor: Apellis Pharmaceuticals

  A Phase II Study for Patients with Geographic Atrophy (GA) due to Age-Related Macular Degeneration (AMD)

  About the Study

  This study is testing APL-3007, an investigational medication designed to slow the growth of GA lesions and help protect retinal cells. It works by lowering a protein in the immune system that contributes to inflammation and retinal damage.

  APL-3007 is given as a subcutaneous (under-the-skin) injection and is studied in combination with Syfovre®, an FDA-approved anti-VEGF ocular injection for GA. Researchers want to see if using both drugs in combination can better slow vision loss and possibly allow for less frequent dosing.

  The study lasts ~18 months and participants are randomly assigned to receive either APL-3007 or placebo, along with Syfovre. Regardless, patients will always receive the standard of care.

  Study Design

  • Phase 2 Trial- Designed to evaluate the safety, tolerability, and effectiveness of APL-3007 when used in combination with Syfovre® for geographic atrophy (GA).
  • Randomized- Participants are randomly assigned to one of the treatment groups to reduce bias and ensure fair comparison.
  • Placebo-Controlled- One group receives a placebo (saline) injection instead of APL-3007, allowing researchers to determine whether APL-3007 provides benefit beyond standard treatment. Placebo participants will still receive the standard of care ocular injection treatment, Syfovre.
  • Combination Therapy- All participants receive Syfovre® intravitreal injections, while also receiving either APL-3007 or placebo as subcutaneous (under-the-skin) injections

  Eligible participants:

  You may be eligible if you:

  • Are 60 years of age or older
  • Have been clinically diagnosed with geographic atrophy due to AMD
  • Have no GA directly under the center of vision (non-subfoveal GA)
  • Have reasonably good vision in the study eye (about 20/100 or better)
  • Have GA lesion size within a specific range of ≥2.5 mm2 and ≤17.5 mm2
  • Have GA lesions located near but not involving the fovea
  • Show certain imaging features that indicate active GA: Non-subfoveal lesion with border of GA lesion not encroaching on the center of the fovea.
  • Are willing to receive required vaccinations (meningitis, pneumonia, flu B)

  Ineligible participants:

  • Current or past wet AMD- Choroidal Neovascularization (CNV) in the study eye
  • Currently receiving ocular injections in the study eye, with the exception of Syfovre.
  • Laser treatment to the macula in the study eye.
  • A history of cancer that has not been successfully treated for at least 1 year
  • Recent participation in another clinical trial.

  Why Refer or Participate?

  • Access to a new treatment, not yet available to the public, designed to slow geographic atrophy, and vision loss. The combination of APL-3007 with Syfovre aims to slow the growth of GA lesions more effectively than current treatment alone, which may help preserve vision longer.
  • Reduction in treatment burden, allowing for patients to go longer intervals between injections.
  • Patients receive regular, comprehensive eye exams, advanced imaging and testing, and close follow-up from our expert retina specialists throughout the 18-month trial.
  • By participating, patients help advance research that may lead to better treatment options for others with GA in the future.
  • Participants receive study medications, exams, and testing at no cost. No insurance required.
  • Complimentary travel support to and from your home to our office for appointments.
  • $100 stipend provided for each completed study visit.

  Referral Support

  Referring providers can contact our clinical research directly for eligibility screening or to discuss specific patient cases. We provide detailed documentation and shared follow-up for all enrolled patients.

  To refer a patient or learn more, call or text 303-261-1600.

  Trial Overview

  • Sponsor: Apellis Pharaceuticals
  • Condition: Geographic Atrophy (GA) due to Age-Related Macular Degeneration (AMD)
  • Study Drug: APL-3007 (subcutaneous + intravitreal)
  • Goal: To evaluate whether oral BI 1584862 can slow or stop GA progression
  • Study Duration: ~18 months
  • Location: Colorado Retina Associates, Lakewood, CO

• SIENNA

  SIENNA Clinical Trial

  Now Enrolling Patients with Geographic Atrophy (GA)

  Sponsor: Regeneron Pharmaceuticals

  Phase: 3 | Study Type: Double-masked, randomized

  About the Study

  The SIENNA trial is a Phase 3 clinical research study evaluating two investigational medications—cemdisiran and pozelimab—for the treatment of Geographic Atrophy (GA), an advanced and irreversible form of dry age-related macular degeneration (AMD).

  This study aims to determine whether cemdisiran, either on its own or in combination with pozelimab, can slow the progression of GA compared to a placebo. Both drugs are designed to modulate the complement system, which plays a critical role in the development of GA.

  How the Study Works

  Participants are randomly assigned to one of three groups:

  1. Cemdisiran + Pozelimab (subcutaneous injection every 4 weeks)
  2. Cemdisiran alone (subcutaneous injection every 4 weeks)
  3. Placebo (subcutaneous injection every 4 weeks)
     The total study duration includes a 14-week screening period and long-term follow-up visits.

  Why Participate?

  • Access to cutting-edge treatment options targeting the root cause of GA progression
  • Close monitoring and comprehensive retinal imaging by retina specialists
  • Help contribute to the future of treatment for patients living with dry AMD
  • Transportation assistance and visit compensation provided

  Inclusion criteria:

  • Age: 55 years or older
  • Study eye with diagnosis of GA of the macula secondary to AMD not involving the foveal center point
  • Total GA area in the study eye measuring between ≥2.5 mm2 and ≤17.5 mm2
  • BCVA SE 20/200 or better
  • Hemoglobin A1C ≤ 8.0% during screening
  • Must have meningococcal/pneumococcal vaccination requirements as described in the protocol

  Exclusion criteria:

  • GA in either eye due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy
  • History or current evidence of macular neovascularization and/or exudation in either eye as described in the protocol
  • Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy as long as last dose was ≥6 months prior to randomization
  • Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study
  • History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
  • History of solid organ or bone marrow transplantation
  • Use of chronic (>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol
  • Current or prior use of systemic immunosuppressive therapy other than corticosteroids or the likelihood of treatment with any such agent during the study inclusive of the screening period

  More Information

  View the full study on ClinicalTrials.gov

  Trial Overview

  • Sponsor: Regeneron Pharmaceuticals
  • Condition: Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD)
  • Type: Phase 3, Double-masked
  • Drugs: Cemdisiran (alone or with Pozelimab) vs. Placebo (all via subcutaneous injection)
  • Goal: Evaluate if cemdisiran (alone or combined with pozelimab) slows GA progression vs. placebo
  • Duration: 14-week screening + long-term follow-up (~2 years total)
  • Location: Colorado Retina Associates, Lakewood, CO
  • ClinicalTrials.gov ID: NCT06541704

• REVEAL

  REVEAL Clinical Trial

  Real-World Evaluation of Izervay® (Avacincaptad Pegol) in Geographic Atrophy

  The REVEAL Study is a long-term, non-interventional clinical research study observing how Izervay®, an FDA-approved treatment for Geographic Atrophy (GA) due to age-related macular degeneration (AMD), is used in routine clinical practice. This trial aims to monitor real-world treatment patterns, safety, and disease progression across a diverse patient population. Note, no injections or medications are provided by the study or sponsor. Patients are treated at their Colorado Retina provider’s discretion.

  Why Participate?

  REVEAL will help researchers and ophthalmologists better understand how patients respond to Izervay outside the controlled setting of clinical trials, ultimately contributing to improvements in care delivery and outcomes.

  Visit Frequency

  Aligned with the patient’s already established care plan and routine clinical visits

  Patient Compensation:

  $25 for the initial screening visit, then $15 for all subsequent follow-up visits.

  Eligibility Criteria

  • Diagnosis of Geographic Atrophy secondary to AMD in 1 or both eyes
  • Being treated with or planning to initiate treatment with Izervay®

  Exclusion Criteria

  • Have any contraindication or are not eligible for treatment with ACP, including the following:
  • Active ocular or peri-ocular infection either eye
  • Active, suspected intraocular inflammation in either eye at enrollment/baseline visit
  • Hypersensitive to ACP or to any ingredient in the formulation
  • Currently participating in an investigational program with interventions outside of routine clinical practice
  • Have received ACP in the study eye.
  • Patients who have received any IVT complement inhibitor other than ACP in either eye in the past 90 days.

  Learn More

  Full study details available at ClinicalTrials.gov

  Trial Overview

  • Sponsor: Astellas Pharmaceuticals
  • Condition: Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD)
  • Study Drug (Observed Use): Avacincaptad Pegol (ACP / Izervay®)
  • End Goal: Evaluate real-world treatment patterns, safety, and disease progression in routine clinical settings
  • Duration: 3–5 years
  • Study Type: Non-interventional / Observational (no study drug provided)
  • Location: Colorado Retina Associates, Lakewood, CO
  • Trial ID: NCT06779773

• ASTELLAS-3021-MA03543

  ASTELLAS-3021-MA03543 Geographic Atrophy (GA) Clinical Trial

  Sponsor: Astellas Pharmaceuticals

  Colorado Retina Associates is participating in a clinical research study evaluating how Izervay™ (avacincaptad pegol) is used in real-world care for patients with geographic atrophy (GA) due to age-related macular degeneration (AMD).

  About the Study

  This is an observational study, meaning it does not test a new treatment. Instead, it collects information from patients already receiving Izervay eye injections as part of their normal care.

  The study helps researchers better understand:

  • How Izervay is used in everyday practice
  • How well it works over time
  • Its safety in real-world patients

  Your doctor will continue to guide your care, treatment decisions are not determined by the study.

  What to Expect & Commitment

  • Continue your regular eye exams and injection treatment
  • Complete brief surveys about your eye health every 6 months, then annually
  • Participation may last up to 3–5 years

  You may be eligible if you:

  • Have been diagnosed with geographic atrophy (GA)
  • Are currently being treated with Izervay injections
  • Are willing to complete surveys about your progress and experience every 6 months-1 year, for 3-5 years.

  Compensation for enrolled patients:

  • $25 for initial screening visit
  • $15 for each completed questionnaire

  Interested or referring a patient?

  Patients and providers can text or call our team at 303-261-1600 to learn more or confirm eligibility. We provide coordinated care and follow-up for all participants.

  Trial Overview

  • Sponsor: Astellas Pharmaceuticals
  • Condition: Geographic Atrophy (GA) due to Age-Related Macular Degeneration (AMD)
  • Study Drug: Izervay Intravitreal Injection (Avacincaptad Pegol)
  • Goal: To evaluate the efficacy and real-world use cases of Izervay
  • Study Commitment: 1 initial research screening visits, then surveys every 6 mons-1 yr, for 3-5 yrs
  • Location: Colorado Retina Associates, Lakewood, CO

Enrolling Diabetic Retinopathy Clinical Trials

• CRIMSON

  CRIMSON Clinical Trial

  Sponsor: Boehringer Ingelheim

  Exploring a New Treatment Option for Diabetic Retinopathy!

  The CRIMSON study is a Phase 2b clinical research trial evaluating the safety and effectiveness of a new investigational treatment, BI 764524, in people with diabetic retinopathy, specifically those who have moderate to severe NPDR and areas of the retina that have lost blood supply (known as retinal non-perfusion).

  The End Goal

  BI 764524 is being tested to restore blood flow to areas of the retina that are damaged by diabetes. By revascularizing ischemic (oxygen-deprived) areas and reducing leakage, the treatment (BI 764524) may help preserve vision and potentially prevent progression to more advanced stages of diabetic eye disease, including vision-threatening complications like proliferative diabetic retinopathy (PDR) or diabetic macular edema (DME).

  The CRIMSON study is double-masked (neither participants nor physician) will know which treatment is being given, to ensure objective results. Participants will be monitored closely with advanced imaging and regular check-ups.

  Eligible Participants:

  • Age: ≥ 18 years
  • Diabetes: Type 1 or 2, on stable treatment ≥ 30 days
  • Visual Acuity: BCVA in study eye ≥ 20/100
  • NPDR Severity: DRSS 47–53 (moderately severe to severe NPDR), confirmed by reading center
  • Retinal Non-Perfusion (RNP): ≥ 12.5 mm² of ischemia on ultra-widefield FA (within 17.5 mm radius centered on fovea)
  • HbA1c: ≤ 12%

  Ineligible Participants:

  • Proliferative diabetic retinopathy in the study eye
  • Clinically significant macular edema (CSME): center-involving DME with CST ≥ 320 µm (men) or ≥ 305 µm (women)
  • Any prior intravitreal treatment for NPDR or DME in the study eye within 6 months using anti-VEGF agents (including anti-VEGF/Ang2 therapies)
  • Any previous intravitreal treatment in the study eye other than anti-VEGF, including steroids
  • Prior panretinal photocoagulation (PRP) involving ≥ 100 burns outside the posterior pole
  • No significant other ocular pathology: retinal vein occlusions, uveitis, endophthalmitis, epiretinal membrane, macular hole, etc.
  • Recent ocular surgery, including cataract surgery in the past 3 months

  Why Participate?

  • Access to a cutting-edge, novel treatment aimed at treating retinal non-perfusion, something no current therapy directly addresses
  • Careful eye health monitoring by retina specialists throughout the study
  • Opportunity to contribute to research that could change the future of diabetic eye care
  • Stipends for participation and travel support may be available
  • May help preserve vision longer and delay or prevent the need for more invasive treatments like ocular injections

  Learn More

  If you're living with diabetic retinopathy and want to explore advanced care options, the CRIMSON trial may be a promising opportunity.

  To refer a patient or learn more, please contact the Colorado Retina Associates research team at 303-261-1600.

  Reference: www. clinicaltrial.be

  Trial Overview

  • Condition: Moderate to severe non-proliferative diabetic retinopathy (NPDR) with retinal non-perfusion
  • Drug: BI 764524 (anti‑Sema3A monoclonal antibody)
  • Study Duration: 72 weeks (~1.5 years)
  • Goal: Improve retinal blood flow by re-vascularizing ischemic areas and reducing leakage
  • Location: Colorado Retina Associates, Lakewood, CO
  • External ID: NCT06321302

Enrolling Diabetic Macular Edema (DME) Clinical Trials

• THULITE

  THULITE Clinical Trial

  Sponsor: Boehringer Ingelheim

  Phase 2 | Randomized, Double-Masked, Placebo-Controlled | Evaluating the efficacy, safety, and tolerability of BI 1815368

  Colorado Retina Associates is enrolling patients in the Thulite (BI-1485-0018) Phase 2 clinical trial, studying a new oral therapy (BI 1815368) for center-involved diabetic macular edema (CI-DME).

  Unlike current treatments that require frequent eye injections, this oral medication can be taken at home, potentially lowering the treatment burden while addressing both eyes at once by targeting the root cause of fluid leakage in the macula.

  Study Purpose

  The goal of the Thulite trial is to determine whether BI 1815368:

  • Improves vision and reduces retinal swelling in patients with CI-DME
  • Offers a systemic treatment option that can address both eyes at once
  • Reduces the long-term treatment burden compared to repeated injections
  • Provides a disease-modifying effect by targeting abnormal blood vessel permeability

  Why This Study is Different

  • Oral Administration: Taken at home, avoiding repeated intravitreal injections
  • Bilateral Benefit: Systemic therapy may treat both eyes and help prevent progression in the unaffected eye
  • Reduced Burden: Fewer office visits compared to current standard of care
  • Targeting the Root Cause: Designed to reduce leakage from abnormal retinal blood vessels, addressing disease at its source

  Eligibility

  To qualify, participants must meet key requirements, including:

  • Age: 18 years or older
  • Diagnosis: Center-involved diabetic macular edema (CI-DME), Type 1 or 2 Diabetes
  • BCVA in Study Eye: 20/32 to 20/320
  • BCVA in Fellow Eye: vision must be better than hand motion
  • HbA1c <12% treated with stable diabetes medication for at least 30 days prior to starting the clinical trial
  • Central Retina Thickness (CST): ≥ 320um for male and ≥305um for women, measured on OCT
  • Blood Pressure: Must be controlled, < 180 systolic and < 100 diastolic while sitting

  Exclusion Criteria

  Patients may not qualify if they:

  • Have uncontrolled systemic disease or very high blood pressure
  • Have a clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
  • Have had any intravitreal injection anti-VEGF treatment within 4 months before day 1 of starting the trial
  • Have had certain recent retinal surgeries or other retinal diseases
  • Are unable to comply with study visits and follow-up

  Ideal Patient Candidate

  • Adults with CI-DME who may benefit from systemic, oral treatment
  • Patients who struggle with or want to reduce the burden of frequent eye injections
  • Patients interested in advancing future therapies for diabetic eye disease

  Study Commitment

  Participation lasts about 48 weeks, requiring 15–16 visits to our Colorado Retina Associates Lakewood office for monitoring, eye exams, and imaging. Each visit helps ensure safety while measuring how well the treatment is working.

  Potential Benefits to Enrolled Patients

  • Access to a novel therapy not yet available to the general population, outside of a clinical trial
  • Comprehensive wellness assessments, and close monitoring of ocular health and diabetes. A VIP experience!
  • Potential to improve vision and reduce swelling caused by DME
  • Potentially helping advance future treatment options that may ease the burden of diabetic eye care for countless patients

  Resources:

  • Clinicaltrials.gov
  • Boehringer Ingelheim
  • Ophthalmology Times

  If you or someone you know has diabetic macular edema and is interested in learning more about the Thulite study, please contact our research team at Colorado Retina Associates for eligibility screening.

  Trial Overview

  • Condition: Diabetic Macular Edema (CI-DME)
  • Drugs: BI 1815368 and Placebo
  • Phase: 2
  • Study Duration: 15–16 visits over 48 weeks
  • Goal: Improves sight in people with CI-DME, while lessening treatment burden
  • Location: Colorado Retina Associates, Lakewood, CO
  • External ID: NCT06962839

• COMO & CAPRI

  COMO & CAPRI Clinical Trials

  Official Study Name: EYP-1901-303 (COMO) and EYP-1901-304 (CAPRI)

  Sponsor: Boehringer Ingelheim

  Two global, Phase 3, randomized, double-masked, controlled clinical trials evaluating the safety and efficacy of DURAVYU™ (vorolanib intravitreal implant, formerly known as EYP-1901) for the treatment of Diabetic Macular Edema (DME)

  Colorado Retina Associates is participating in two clinical research studies evaluating a longer-lasting treatment option for people with diabetic macular edema (DME), a condition that causes swelling in the retina and can affect vision.

  What is being studied?

  These studies are testing a new treatment called DURAVYU™, a small implant placed in the eye that may last up to 6 months. DURAVYU™ is being compared to a standard treatment (Eylea® injections), which are typically given every 4 weeks-2 months.

  👉 The goal is to see if this new option can reduce how often patients need injections while still maintaining vision and controlling swelling.

  What to expect

  • You will receive either the new implant or standard injections
  • All treatments are FDA-approved or commonly used, but the implant is still being studied
  • Visits and treatments are carefully scheduled and monitored
  • Some visits may include “sham” (no medication) procedures to keep the study fair
  • Your eye health and vision will be closely followed throughout the study
  • Who may qualify?

  You may be eligible if you:

  • Are 18 or older
  • Have diabetic macular edema (DME)
  • Have type 1 or type 2 diabetes
  • Have received at least one prior eye injection for DME in the past year
  • Meet certain vision and eye health criteria

  Why consider participating?

  • Access to a potentially longer-lasting treatment
  • May reduce the need for frequent injections
  • Close monitoring by retina specialists
  • Help advance future treatments for DME patients

  Interested?

  Talk to your doctor or contact our clinical research team to learn if this study may be a good fit for you.

  Trial Overview

  • Condition: Diabetic Macular Edema
  • Treatment: DURAVYU™ ocular implant
  • Phase: 3
  • Study Duration: ~1.7 years
  • Goal: Improve sight and provide a 6-month re-dosing interval to reduce the treatment burden for patients.
  • Location: Colorado Retina Associates, Lakewood, CO
  • Trial Identifiers: COMO: NCT07449936 / CAPRI: NCT07449923

Macular Telangiectasia (MacTel) Clinical Trials

• NEUROTECH-NTMT-04

  Macular Telangiectasia (MacTel)- NEUROTECH-NTMT-04 Clinical Trial

  Sponsor: Neurotech Pharmaceuticals, Inc.

  This study is for patients with Macular Telangiectasia (MacTel) who have previously participated in a clinical trial involving the NT-501 implant.

  The goal is to better understand the long-term safety and effectiveness of this new implant, called:
  revakinagene taroretcellwey (NT-501)

  👉 This is a extension study, meaning that it does not enroll new, never-treated patients. And it continues to monitor patients who were already part of earlier MacTel clinical studies.

  What is the NT-501 implant?

  NT-501 is a small device placed inside the eye that continuously releases a therapeutic protein designed to help protect retinal cells and slow disease progression.

  Study Design

  Participants are placed into one of three groups based on their prior study participation:

  1. Arm 1: Patients who already received the implant in a Phase 3 trial → monitored long-term
  2. Arm 2: Patients who received the implant in earlier Phase 1 or 2 trials → monitored long-term
  3. Arm 3: Patients who previously received a sham (placebo) procedure → now have the option to receive the implant
     *Most participants are being observed over time, rather than receiving new treatment (except Arm 3).

  Commitment

  • Screening period: ~3 weeks
  • Study visits: Over 8–16 weeks initially, with longer-term follow-up

  Patient Qualification Criteria:

  • Have a clinical diagnosis of MacTel
  • Have previously participated in an NT-501 clinical trial
  • Be able to maintain steady fixation (look steadily at a target)
  • Have clear enough vision/media for quality retinal imaging

  Who may NOT qualify?

  • Unable to attend visits or follow study procedures
  • Medical or mental health conditions that could affect safety or participation
  • Additional exclusions (especially for patients receiving a new implant):
  • Significant corneal or vision-blocking issues
  • High myopia
  • Recent injection treatments in the study eye, including: steroid injections (within 1 year), anti-VEGF injections (within 6 months)
  • Evidence of active exudative intraretinal neovascularization or subretinal neovascularization in the study eye, as evidenced by hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid.
  • Central serous chorioretinopathy
  • Prior major ocular surgery: e.g., vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty

  Why is this study important?

  MacTel is a progressive retinal condition with limited treatment options. This study helps determine whether the NT-501 implant can safely protect retinal cells over time and slow vision loss in the long term.

  Key takeaways for referring providers

  • This is a closed-loop extension study (not open to new, treatment-naïve patients)
  • Ideal referrals = patients previously enrolled in NT-501 trials
  • Arm 3 offers a treatment opportunity for prior sham patients

  Trial Overview

  • Condition: Macular Telangiectasia
  • Drugs: NT-501 ocular implant
  • Key Inclusion: previously enrolled in MacTel NT-501 trials
  • Study Duration: up to 21 weeks
  • Goal: Determine efficacy and safety of an implated device that helps protect retinal cells and slows MacTel disease progression
  • Location: Colorado Retina Associates, Lakewood, CO