Pozelimab + Cemdisiran for Macular Degeneration

(SIENNA Trial)

Recruiting at 69 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Regeneron Pharmaceuticals

Must be taking: Meningococcal, Pneumococcal vaccines

Must not be taking: Systemic corticosteroids, Immunosuppressive therapy

Disqualifiers: Diabetic retinopathy, Macular edema, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

750 Participants Needed

Trial Summary

What is the purpose of this trial?

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)

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using systemic complement inhibitor therapy, chronic systemic corticosteroids, or systemic immunosuppressive therapy, you may not be eligible to participate.

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

Key

My study eye has a specific type of age-related macular degeneration not affecting the central vision area.

The affected area in my eye is between 2.5 and 17.5 mm2.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pozelimab in combination with cemdisiran, cemdisiran alone, or placebo to evaluate the progression rate of Geographic Atrophy

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including side effects and antibody development

12 weeks

Treatment Details

Interventions

• Cemdisiran
• Pozelimab

Trial Overview 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.

Participant Groups

Group I: Pozelimab + Cemdisiran treatment group Experimental Treatment 2 Interventions

Randomized 1:1:1

Group II: Cemdisiran monotherapy treatment group Experimental Treatment 1 Intervention

Randomized 1:1:1

Group III: Placebo treatment group Placebo Group 1 Intervention

Randomized 1:1:1

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School