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Pozelimab + Cemdisiran for Macular Degeneration (SIENNA Trial)

Phase 3
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Key
1. Study eye with diagnosis of GA of the macula secondary to AMD not involving the foveal center point as described in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

"This trial is testing two new drugs, pozelimab and cemdisiran, on patients with geographic atrophy caused by age-related macular degeneration. The goal is to see if these

Who is the study for?
This trial is for adults with geographic atrophy (GA) due to age-related macular degeneration. Participants must have a certain level of vision in the study eye, an area of GA that fits specific size criteria, and be able to undergo required vaccinations. Those with GA affecting the center point of the fovea or who cannot complete imaging procedures are excluded.
What is being tested?
The trial examines if pozelimab combined with cemdisiran or cemdisiran alone can slow down GA progression compared to a placebo. It also studies side effects, drug levels in blood over time, and potential antibody development against these drugs.
What are the potential side effects?
Potential side effects from pozelimab and cemdisiran may include immune reactions such as developing antibodies against the drugs which could reduce effectiveness or cause other adverse effects; detailed side effect profiles will be investigated during this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My study eye has a specific type of age-related macular degeneration not affecting the central vision area.
Select...
My eyes can be clearly imaged for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pozelimab + Cemdisiran treatment groupExperimental Treatment2 Interventions
Randomized 1:1:1
Group II: Cemdisiran monotherapy treatment groupExperimental Treatment1 Intervention
Randomized 1:1:1
Group III: Placebo treatment groupPlacebo Group1 Intervention
Randomized 1:1:1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pozelimab
2020
Completed Phase 3
~130
Cemdisiran
2020
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
385,074 Total Patients Enrolled
46 Trials studying Macular Degeneration
23,795 Patients Enrolled for Macular Degeneration
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,167 Total Patients Enrolled
12 Trials studying Macular Degeneration
2,236 Patients Enrolled for Macular Degeneration
~500 spots leftby Nov 2027
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