Investigating a new treatment for geographic atrophy in age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of pozelimab and cemdisiran, either alone or in combination, on the progression of geographic atrophy (GA) in adults with age-related macular degeneration (AMD). Participants will receive either the study drugs or a placebo, and the study will monitor the progression of GA, side effects, drug levels in the blood, and the body's immune response to the drugs. The goal is to determine the efficacy and safety of these treatments in slowing down GA progression.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
2. Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
3. BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol

Key Exclusion Criteria:

1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy
2. History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol
3. 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 or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization
4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization
5. 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
6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol

   Systemic Exclusion criteria
7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
8. History of solid organ or bone marrow transplantation
9. 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
10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol
11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol
12. Carrier of Neisseria meningitidis based on culture collected during screening
13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol

NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Where it's running

• Barnet Dulaney Perkins Eye Center-Ophthamalogy
  Chandler, Arizona, United States Recruiting
• Barnet Dulaney Perkins Eye Center
  Phoenix, Arizona, United States Recruiting
• Associated Retina Consultants
  Phoenix, Arizona, United States Recruiting
• Retinal Research Institute
  Phoenix, Arizona, United States Recruiting
• Retina Macula Institute of Arizona
  Scottsdale, Arizona, United States Recruiting
• Retina Associates of Tuscan
  Tucson, Arizona, United States Recruiting

+183 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Eye injection of pozelimab for geographic atrophy in adults

  This study will test whether injections of pozelimab into the eye are safe and well tolerated in adults with geographic atrophy from age-related macular degeneration.

  Recruiting at 9 sites Phase 1 Regeneron Pharmaceuticals · Lakewood, Colorado and 8 other locations · NCT07230834

• ONL1204 injections for geographic atrophy from age-related macular degeneration

  This trial will try intravitreal ONL1204 injections at two doses and two schedules in people 55 and older with geographic atrophy from AMD to see if it slows lesion growth and is safe.

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• Enhanced vision and imaging tests to enable treatments for early and intermediate AMD

  We will see if a fundus-tracked dark adaptometry test can reliably detect and track vision changes in people with early or intermediate AMD and in healthy volunteers.

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• Finding protein biomarkers for AMD, diabetic retinopathy, and retinal detachment

  This project will test whether proteins found in blood and eye fluids can help diagnose or predict outcomes for adults with AMD, diabetic retinopathy, or retinal detachment.

  Recruiting Fondazione G.B. Bietti, IRCCS · Roma, Italy · NCT07500324

• Early response to Eylea 8 mg in neovascular (wet) age-related macular degeneration

  This observational project will try Eylea (aflibercept) 8 mg eye injections to see how retinal fluid and vision change over the first two months in people with active neovascular AMD.

  Recruiting Insel Gruppe AG, University Hospital Bern · Bern · NCT07434713

• SING IMT implant for pseudophakic patients with advanced AMD

  This study will test whether the SING IMT™ implant, placed either on top of or replacing an existing intraocular lens, can improve central vision in people with advanced AMD who already have IOLs.

  Recruiting at 12 sites VisionCare, Inc. · Marseille and 11 other locations · NCT07164378

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.