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    Wet Age-Related Macular Degeneration Clinical Trials

    • 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

    Enrolling Geographic Atrophy Clinical Trials

    • 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

    Enrolling Diabetic Retinopathy Clinical Trials

    • 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 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:

      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

    Macular Telangiectasia (MacTel) Clinical Trials

    • 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