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Clinical Trials in the USA / NCT06541704
Recruiting Phase 3

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

NCT06541704 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 3
Started
2024-10-30
Last updated
2026-08-25

Condition(s) studied

Age-related Macular Degeneration (AMD)Geographic Atrophy (GA)

Investigational drug(s) / intervention(s)

PozelimabCemdisiranPlacebo

Pozelimab: Subcutaneous (SC) injection

Cemdisiran: SC injection

Placebo: SC injection

Study 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)

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (224)

FacilityCityRegionStatus
Barnet Dulaney Perkins Eye Center-Ophthamalogy Chandler Arizona Recruiting
Barnet Dulaney Perkins Eye Center Phoenix Arizona Recruiting
Associated Retina Consultants Phoenix Arizona Recruiting
Retinal Research Institute Phoenix Arizona Recruiting
Retina Macula Institute of Arizona Scottsdale Arizona Recruiting
Retina Associates of Tuscan Tucson Arizona Recruiting
Retina Partners of Northwest Arkansas, PLLC Springdale Arkansas Recruiting
Retina Vitreous Associates Medical Group Beverly Hills California Recruiting
Retina Specialists of Beverly Hills- Department of Ophthalmology Beverly Hills California Recruiting
The Retina Partners Encino California Completed
Eye Medical Center of Fresno Fresno California Recruiting
Retina Consultants of Orange County Fullerton California Completed
Salehi Retina Institute dba Retina Associates of Southern California Huntington Beach California Recruiting
University of California Irvine Irvine California Recruiting
University of California San Diego, Jacobs Retina Center La Jolla California Recruiting
South Coast Retina Center Long Beach California Recruiting
American Institute of Research Los Angeles California Completed
Kaiser Permanente Los Angeles Medical Center Los Angeles California Recruiting
Jules Stein Eye Institute in David Geffen School of Medicine at UCLA Los Angeles California Recruiting
Retinal Consultants Medical Group Inc Modesto Modesto California Recruiting
Northern California Retina Vitreous Associates Medical Group, Inc. Mountain View California Recruiting
California Retina Consultants Oxnard California Recruiting
Desert Retina Consultants Palm Desert California Withdrawn
California Eye Specialists Medical Group Inc. Pasadena California Recruiting
Retina Consultants San Diego Poway California Recruiting
California Eye Specialists Medical Group, Inc. Redlands California Recruiting
Optic Eye Care Rowland Heights California Recruiting
UC Davis Health Eye Center Sacramento California Recruiting
Vrmg Inc Sacramento California Recruiting
Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center Sacramento California Recruiting
West Coast Retina Medical Group, Inc. San Francisco California Recruiting
Orange County Retina Medical Group Santa Ana California Recruiting
Macula Retina Vitreous Research Institute Torrance California Recruiting
University of Colorado Aurora Colorado Recruiting
Retina Consultants of Southern Colorado Colorado Springs Colorado Recruiting
Retina Specialists of Colorado - Denver Denver Colorado Recruiting
Southwest Retina Research Center Durango Colorado Recruiting
Colorado Retina - Lakewood Lakewood Colorado Recruiting
Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute Longmont Colorado Recruiting
Retina Group of New England Waterford Connecticut Terminated

+ 184 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06541704 on ClinicalTrials.gov ↗ ← All trials in the USA