Summary

Eligibility
for people ages 50-85 (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

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). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).

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.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug(s)
  • How much study drug(s) are in the blood at different times
  • Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Official Title

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Keywords

Age-related Macular Degeneration (AMD), Geographic Atrophy (GA), GA secondary to AMD, Macular Degeneration, Geographic Atrophy, Counterfeit Drugs, Pozelimab, Cemdisiran

Eligibility

You can join if…

Open to people ages 50-85

  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 mm2 and ≤17.5 mm2 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

You CAN'T join if...

  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

Locations

  • University of California San Diego, Jacobs Retina Center accepting new patients
    La Jolla 5363943 California 5332921 92093 United States
  • West Coast Retina Medical Group, Inc. accepting new patients
    San Francisco 5391959 California 5332921 94109 United States
  • Retina Vitreous Associates Medical Group accepting new patients
    Beverly Hills 5328041 California 5332921 90211 United States
  • The Retina Partners accepting new patients
    Encino 5346649 California 5332921 91436 United States
  • Orange County Retina Medical Group accepting new patients
    Santa Ana 5392900 California 5332921 92705 United States
  • Salehi Retina Institute dba Retina Associates of Southern California accepting new patients
    Huntington Beach 5358705 California 5332921 92647 United States
  • American Institute of Research accepting new patients
    Los Angeles 5368361 California 5332921 90017 United States
  • Retina Consultants San Diego accepting new patients
    Poway 5384690 California 5332921 92064 United States
  • Macula Retina Vitreous Research Institute accepting new patients
    Torrance 5403022 California 5332921 90503 United States
  • Retina Consultants of Orange County accepting new patients
    Fullerton 5351247 California 5332921 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT06541704
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 975 study participants
Last Updated