Pozelimab for Macular Degeneration

(VIENNA Trial)

Recruiting at 1 trial location

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Systemic complement inhibitors

Disqualifiers: Macular neovascularization, Retinal exudation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called pozelimab, an experimental drug for people with geographic atrophy, a condition where parts of the retina deteriorate, leading to vision loss. The main goal is to determine if this treatment is safe and tolerable when injected into the eye. Researchers will also examine possible side effects, how the drug moves in the body, and whether the body creates antibodies that might interfere with the drug. Suitable candidates for this trial include those diagnosed with geographic atrophy related to age-related macular degeneration and who have significant vision challenges in one eye. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that pozelimab is likely to be safe for humans?

Research has shown that pozelimab, the study drug, is being tested for safety and tolerability in people with geographic atrophy (GA), a condition where parts of the eye's retina stop functioning. Previous patients have generally tolerated pozelimab well when administered in other forms, such as injections under the skin. However, since this study involves injections directly into the eye, monitoring for specific side effects related to this method is crucial.

In other studies, pozelimab has been designed to target immune system pathways, potentially slowing or stopping retinal damage. While detailed data on side effects from eye injections is not yet available, researchers are closely monitoring for any issues. They also assess the drug's concentration in the body and whether the body produces antibodies against it, which could affect efficacy or cause side effects.

This study is in its early phase, primarily focused on understanding safety. If serious side effects were common, the drug likely would not have progressed to this stage. The goal is to gather more safety information before considering wider use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for macular degeneration?

Unlike the standard treatments for macular degeneration, which often involve anti-VEGF injections like ranibizumab or aflibercept, Pozelimab is unique because it targets a different pathway in the disease process. Researchers are excited about Pozelimab because it acts on the complement system, which plays a role in inflammation and tissue damage associated with macular degeneration. This new mechanism of action offers a promising alternative for patients, potentially providing benefits where current treatments may be less effective.

What evidence suggests that pozelimab might be an effective treatment for geographic atrophy?

Research shows that pozelimab targets a part of the immune system that might contribute to geographic atrophy (GA). Although specific data on its effectiveness for GA is limited, similar treatments have shown promise in slowing the disease. Pozelimab has proven effective in other conditions, such as myasthenia gravis, suggesting its potential against immune-related diseases. This trial will investigate pozelimab in two parts, Part A and Part B, to assess its safety and the body's response, which will help determine its potential for treating GA. More research is needed to confirm its specific effectiveness for GA. ^{1 3 4 6 7}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with geographic atrophy (GA) due to age-related macular degeneration. Participants must have a certain size of GA in one eye and vision that's around 20/63 or worse. People can't join if they don't meet the specific criteria for GA size or visual acuity as determined by the study's guidelines.

Inclusion Criteria

My vision in the study eye is about 20/63 or worse, even with the best correction.

Key

1. Study eye with diagnosis of GA of the macula secondary to AMD, as determined by the investigator 2. Study eye with total GA area measuring approximately one disc area or greater in size (2.5 mm\^2 or larger) at screening, as determined by the Central Reading Center (CRC), as described in the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive intravitreal pozelimab injections to assess safety and tolerability

8 weeks

Regular visits for monitoring and injections

Treatment Part B

Continued treatment with pozelimab to further assess safety, tolerability, and pharmacokinetics

16 weeks

Regular visits for monitoring and injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pozelimab

Trial Overview

The trial is testing Pozelimab, an experimental drug, given as an eye injection to see how safe it is and what side effects might occur. It also measures how much of the drug stays in the blood and eye fluid over time, and checks if the body creates antibodies against it.

How Is the Trial Designed?

Group I: Part B Experimental Treatment 1 Intervention

Group II: Part A Experimental Treatment 1 Intervention

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

Citations

1.

ucihealth.org

ucihealth.org/clinical-trials/ccr-24-115

sienna

Official Title: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06541704

NCT06541704 | A Study Investigating Subcutaneously ...

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 ...

3.

newsroom.regeneron.com

newsroom.regeneron.com/news-releases/news-release-details/regeneron-announces-positive-results-phase-3-trial-generalized

Regeneron Announces Positive Results from Phase 3 Trial ...

“The results of the NIMBLE trial confirm that, in myasthenia gravis, robust efficacy can be achieved without complete complement blockade, ...

4.

synapse.patsnap.com

synapse.patsnap.com/article/how-does-pozelimabcompare-with-other-treatments-for-amd

How does Pozelimabcompare with other treatments for ...

While anti-VEGF therapies have robustly improved short-term vision outcomes in neovascular AMD, they have had no impact on dry AMD. Should ...

5.

clinicaltrials.eu

clinicaltrials.eu/trial/study-of-pozelimab-and-cemdisiran-for-adults-with-geographic-atrophy-from-age-related-macular-degeneration/

Study of Pozelimab and Cemdisiran for Adults with ...

This trial aims to provide valuable information on the safety and effectiveness of these treatments for individuals with Geographic Atrophy due ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07230834

Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in ...

The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called ...

7.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/REGN/pressreleases/37085666/regeneron-advances-early-stage-eye-drug-pozelimab-in-geographic-atrophy-trial/

Regeneron Advances Early-Stage Eye Drug Pozelimab in ...

The drug is designed to act on the immune system pathways believed to drive retinal damage, with the aim of slowing or stabilizing the loss of ...