A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cem… (NCT06541704) | Clinical Trial Compass
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
United States, Austria, Canada975 participantsStarted 2024-10-30
Plain-language 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)
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
. Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
. BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial combining two drugs — pozelimab given as a subcutaneous injection and cemdisiran — to try to slow the growth of geographic atrophy lesions; can you explain what we already know about the safety and effectiveness of this combination, and how that compares to what's available to me right now as standard care?
2The trial measures how quickly my GA lesion area grows using a test called Fundus Autofluorescence over time — how often would I need to come in for these imaging visits, and is that level of commitment realistic for my situation?
3Since pozelimab is given as a subcutaneous injection, does that mean I or a caregiver would need to learn to give injections at home, or would I need to come into a clinic each time?
4One arm of this study uses cemdisiran alone while another combines it with pozelimab — is there a way to know which arm I'd be placed in, and how would being in the cemdisiran-only group affect my care compared to the combination group?
5Given that geographic atrophy currently has very limited treatment options, would you recommend I consider joining this trial now, or are there other approved treatments or studies I should look at first before committing to this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF)
. 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 (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) 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 or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization
. 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
. 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
. 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
. 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