What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD), particularly those targeting geographic atrophy (GA) lesion formation or progression, include intravitreal injections such as anti-VEGF therapies (e.g., ranibizumab, aflibercept). Known side effects of these treatments can include eye pain, vitreous floaters, increased intraocular pressure, and risk of intraocular inflammation or infection. Additionally, there may be transient visual disturbances and, rarely, retinal detachment or hemorrhage. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD), particularly for the neovascular (wet) form of AMD. These include anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin). These drugs work by inhibiting the growth of abnormal blood vessels in the retina. For geographic atrophy (GA), a form of dry AMD, there are fewer approved treatments. However, recent advancements include the approval of pegcetacoplan (Empaveli), which targets the complement pathway implicated in GA progression. The investigational drug JNJ-81201887 (AAVCAGsCD59) being studied aims to address GA by potentially inhibiting pathways involved in lesion growth, similar to how pegcetacoplan targets the complement system.

What other types of research exist?

Promising novel alternatives for treating geographic atrophy secondary to AMD include: 1) Pegcetacoplan, a complement C3 inhibitor, which has shown efficacy in reducing GA lesion growth. 2) Zimura (avacincaptad pegol), a complement C5 inhibitor, which has demonstrated a reduction in the progression of GA. Both treatments are in advanced clinical trials and target pathways involved in GA lesion formation.

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Virus Therapy

JNJ-81201887 for Geographic Atrophy Due to Age-Related Macular Degeneration

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and month 18

Summary

This trial is testing a new treatment called JNJ-81201887 to see if it can slow down the growth of damaged areas in the eyes of people with geographic atrophy. This condition causes parts of the retina to deteriorate, and the treatment aims to protect the retina and preserve vision.

Who is the study for?

This trial is for adults with a specific eye condition called non-subfoveal geographic atrophy due to age-related macular degeneration. The affected area must be visible and measurable, and their other eye should have minimal vision of counting fingers or better. People with active eye infections, certain retinal diseases, previous specific treatments in the study eye region, or history of retinal detachment cannot participate.

What is being tested?

The trial is testing JNJ-81201887, an investigational drug delivered into the eye (intravitreal injection), against a sham procedure (a fake treatment that mimics the real procedure without delivering medication) to see if it slows down lesion growth in patients with geographic atrophy.

What are the potential side effects?

Potential side effects may include discomfort from injections like redness or pain at the injection site, increased risk of infection inside the eye (endophthalmitis), possible inflammation within the eye structures, and elevated pressure inside the eyeball.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and month 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and month 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and month 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18

Secondary study objectives

Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18

Change From Baseline in Functional Reading Independence (FRI) Index at Month 18

Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm B: JNJ-81201887 High doseExperimental Treatment3 Interventions

Participants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.

Group II: Arm A: JNJ-81201887 Low DoseExperimental Treatment3 Interventions

Participants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.

Group III: Arm C: Sham ProcedurePlacebo Group2 Interventions

Participants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the long acting periocular corticosteroid injection (triamcinolone) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Triamcinolone

2016

Completed Phase 4

~1220

Prednisone

2014

Completed Phase 4

~2500

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Age-Related Macular Degeneration (AMD) often target pathways involved in retinal damage and lesion growth. Anti-VEGF therapies reduce abnormal blood vessel growth and leakage, while complement inhibitors address the immune system's role in inflammation and cell damage. Treatments like JNJ-81201887 likely focus on specific pathways involved in geographic atrophy (GA) lesion formation, offering potential to slow or halt disease progression. Understanding these mechanisms is crucial for AMD patients as it helps preserve vision and improve quality of life by addressing the root causes of retinal degeneration.