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• Wet AMD

• Geographic Atrophy

Enrolling Wet Macular Degeneration Clinical Trials

• SOL-R

  SOL-R

  Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration.

  ClinicalTrials.gov ID: NCT06223958
  Sponsor: Ocular Therapeutix, Inc.

  Condition: Neovascular Age-Related Macular Degeneration
  Intervention / Treatment:

  • Drug: OTX-TKI (axitinib implant)
  • Drug: Aflibercept

  Study Design: 2:2:1

  • Experimental: OTX-TKI (axitinib implant) at Day 1 and WK 24, or
  • small, resorbable product, that consists of hydrogel implant loaded with axitnib, injected into the vitreous. 
  • Expected to take 9 to 10.5 months to completely resorb.
  • IVT Aflibercept Injection of 2mg starting at Day 1 and every Q8W thereafter through WK40, or
  • IVT Aflibercept 8mg at Day 1 and Week 24
    OTK-TKI, axitnib, is approved by the FDA as an oral medication for the treatment of advanced renal cell carcinoma.

  Inclusion criteria

  • Age: 50 years or older
  • Diagnosis: wAMD previously treated with up to 3 IVTs of anti-VEGF (except BEOUV) 4 Months prior to screening (4-week washout)
  • Tx naive subfoveal neovascularization or juxta foveal NV secondary to wAMD
  • BCVA: 20/200 or better
  • FE BCVA: 20/400 or better

  Exclusion criteria

  • CNV due to diseases other than AMD in SE that could affect vision or safety assessments
  • Scar, fibrosis, or atrophy of >50% of the total lesion in the SE
  • Current or prev. treatment with: Syfovre or Izervay for GA in SE.
  • For FE, allowed with a 3 Month wash out.
  • Previous laser photocoagulation, PDT to the macula in SE
  • Planned intraocular surgery in SE during the duration of the study.
  • In the past 3 Months received: Cataract surgery, lasik, PRK, or anterior segment surgery
  • Vitreoretinal surgery of other ocular surgeries including scleral buckle or glaucoma filtering/ shunt surgery.
  • Gene therapy or Ranibizumab PDS in either eye
  • Aphakia or sulcus intraocular lens in SE
  • Advanced glaucoma, ocular malignancy (choroidal melanoma)
  • Patient on medications with retinal toxicity.
  • Uncontrolled diabetes HbA1c >10%
  • AMI or other cardiovascular event in the past 6 Months
  • Uncontrolled Hypertension (>160/100)

• LUCIA

  LUCIA

  Phase 3, 99WKS, TKI Inhibitor, nAMD

  Sponsor: EyePoint Pharaceuticals

  Global, randomized, double-masked, aflibercept controlled, non-inferiority Phase 3 trial assessing the efficacy and safety of DURAVYU in patients with active wet AMD including previously treated and treatment-naïve patients. Enrolled participants will be randomly assigned to a 2.7mg dose of DURAVYU or an on-label aflibercept control.

  The LUCIA trial is the only sustained release wet AMD pivotal Phase 3 trial evaluating re-dosing. Patients in the DURAVYU treatment arm will receive an intravitreal injection of DURAVYU every six months, starting at month two of the trial. DURAVYU is delivered via a standard intravitreal injection in the physician's office, similar to current standard practice with FDA approved anti-VEGF treatments.

  The primary endpoint of the trial is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 versus baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections and anatomical results as measured by optical coherence tomography (OCT).

  Study Design:

  • Experimental: EYP-1901-301
  • Subjects will receive IVY Eylea 2mg at Day 1 and at WK4.
  • At WK8 subjects will receive IVT Eylea + EYP-1901 IVT insert.
  • At WK32,56, and 80 will receive only EYP-1901 dose.
  • Control: IVT Aflibercept 
  • Subjects will receive IVT Eylea 2mg at Day 1 and at WK4,WK8, and every 8WKS  

  Inclusion criteria:

  • Age: 50 years or older
  • BCVA 20/32- 20/200 SE
  • BCVA FE 20/400 or better
  • Decrease in BCVA due to wAMD
  • Treatment Naïve
  • Prev. Tx must have been treated with at least 2 anti-VEGF injections in the previous 6 months for wAMD per soc in the SE 
  • Previously tx subjects, demonstrated anatomical response to IVT anti-VEGF medications in the last 6 months 
  • Most recent anti-VEGF tx must not be less than 6 weeks prior to screen visit 
  • Active subfoveal CNV due to wAMD, including juxtafoveal lesions that affect the fovea
  • IRF or SRF affecting the central subfield as measured by SD-OCT
  • Total lesions size of ≤ 9 disc areas
  • Total area of CNV must comprise greater than 50% of the total lesion area 

  Exclusion criteria:

  • CST >500um at screening visit
  • Intraretinal cycstic fluid >35um in diameter involving the central subfield
  • Fibrosis >50% of the total lesion
  • Subfoveal fibrosis, atrophy, or scarring in the center subfoveal
  • Subretinal hemorrhage in the subfoveal/juxtafoveal location and hemorrhage greater than 1 disc area if located <300um from the foveal center
  • RPE tear
  • RPED thickness >400
  • H/o PPV, submacular sx, or other surgical intervention for wAMD
  • Previous focal laser photocoagulation used for wAMD tx
  • Previous use of IVT brolucizumab or EYP-1901 in the SE
  • Previous use of Syfovre and Izervay for GA

• ATMOSPHERE

  ATMOSPHERE

  ABBV-RGX-314 is being developed as a potential one-time treatment for wet age-related macular degeneration (AMD) treated with anti-VEGF.

  Sponsor: RegenXBio

  ABBV-RGX-314 is being developed as a novel, one-time subretinal treatment that includes the NAV® AAV8 vector containing a gene encoding for a monoclonal antibody fragment. The expressed protein is designed to neutralize vascular endothelial growth factor (VEGF) activity, modifying the pathway for formation of new leaky blood vessels and retinal fluid accumulation.

  ATMOSPHERE® is evaluating the subretinal delivery of ABBV-RGX-314 in patients with wet AMD.

  Study design:

  • 1:1:1 randomization at screen visit 3

  • Cohort 1: Single dose of 3.2 x 10^11 GC/mL (Low-dose)
  • Cohort 2: Single dose of 6.5 x 10^11 GC/mL (High-dose)
  • Cohort 3: Monthly Ranibizumab through WK 54 (control)

  • Ranibizumab control subjects who are eligible will be offered the option after WK 54 to cross over to RGX-314 and receive the highest tolerated dose at WK 56. 

  Inclsuion criteria:

  • Age: 50 – 89 (inclusive)
  • BCVA: 20/25 - 20/160 (inclusive)
  • CNV with fluid within 3 mm center of macula
  • Pseudophakic for at least 12 weeks prior to screen
  • WK1 response: improvement in fluid and CRT <400
  • Improvement in inner retinal fluid of > 50 relative to screen visit 1
  • Or any improvement in fluid if < 50 at screen visit 1
  • BP: 180/100 or better

  Exclusion criteria:

  • Sub foveal fibrosis or atrophy
  • 12 anti-VEGF injections in 12 months prior to screen visit 1
  • nAMD diagnosed greater than 4 yr. prior to screen
  • IVT steroids within 6 months prior to screen visit 1
  • Previously received gene therapy
  • History of RD, retinal tear, or retinal toxicity
  • MI, CVA, or TIA within the 6 months prior to screen

Enrolling Geographic Atrophy Clinical Trials

• Garland

  Garland

  Observational Study - Phase 4

  Sponsor: Apellis Pharmaceuticals, Inc.

  A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration.

  The purpose of this study is to assess real-world treatment patterns of Syfovre given to participants with geographic atrophy (GA) in one or both eyes.

  ClinicalTrials.gov ID: NCT06161584
  Duration: 36 months
  Intervention / Treatment: Pegcetacoplan

  Inclusion criteria:

  Eyes are eligible to be included in the study only if all of the following criteria apply. Ocular-specific inclusion criteria apply to the treated eye(s).

  • Age: 60 years or older
  • BCVA: 20/200 or better
  • Eyes that are tx naïve with pegcetacoplan that are prescribed pegcetacoplan per routine 
  • Clinical dx of GA of the macula secondary to AMD in one or both eyes as determined by OCT/and or FAF 
  • Non subfoveal lesions
  • GA lesion not contiguous with any areas of peripapillary atrophy
  • Presence of any pattern of hyperautofluorescence in the junctional zone of GA

  Exclusion criteria:

  • GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy, or toxic maculopathies like Plaquenil maculopathy in either eye 
  • active, suspected, or history of intraocular inflammation in either eye at screening or on day 1
  • any history of or active choroidal neovascularization associated with AMD or any other causes, including any evidence of retinal pigment epithelial tears or rips in SD-OCT imaging
  • presence of an active ocular disease that in the opinion of the investigator compromises or confounds visual function, including but not limited to uveitis and other macular disease 
  • any prior treatment with anti-VEGF agents
  • intraocular surgery (including lens replacement surgery) within 3 months prior to screening 
  • history of laser therapy in the macular region
  • aphakia or absence of the posterior capsule opacification done at lease 60 days prior to screening is not exclusionary
  • any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period
  • any contraindication to IVT injection 
  • intravitreal medical device placement 
  • history or current use of brolucizumab and/or pharmacological treatments that gain approval for the treatment of GA

• Sienna

  Sienna

  Phase 3, Double-masked

  Sponsor: Regeneron Pharmaceuticals

  A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy (SIENNA)

  This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have geographic atrophy (GA) caused by age-related macular degeneration (AMD). The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.

  Study Design: 3 patient groups, including a placebo group

  1. Drug: SC Q4W Pozelimab + Cemdisiran treatment group
  2. Drug: SC Q4W Cemdisiran monotherapy treatment group
  3. Drug: SC Q4W Placebo

  Duration: 2 screening visits (14-week period)

  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