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

Not currently recruiting at 205 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Diabetic retinopathy, Retinal detachment, others

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

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

Compensation: Varies

Number of Visits: 19

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment, JNJ-81201887, for individuals with geographic atrophy (GA), a condition linked to age-related macular degeneration (AMD). The goal is to determine if this treatment can slow the growth of GA lesions in the eye compared to a placebo. Participants will be divided into groups to receive different doses of the treatment or a sham procedure (placebo). The trial seeks individuals with GA that can be clearly photographed and does not affect the very center of their vision. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that JNJ-81201887 is usually well-tolerated when injected into the eye. In earlier studies, most participants did not experience serious side effects, with common reactions including mild eye irritation or redness.

Other studies are examining the long-term safety of this treatment. So far, it has maintained a good safety record over time, with serious problems being uncommon among those receiving the treatment over months or years.

Since this study is in an early phase, it primarily focuses on assessing the treatment's safety for participants. For those considering joining this trial, past research suggests that serious risks are low. However, it is important to consult a doctor to understand what this could mean for individual circumstances. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about JNJ-81201887 because it represents a novel approach to treating geographic atrophy due to age-related macular degeneration (AMD). Unlike current treatments that primarily focus on managing symptoms or slowing progression, JNJ-81201887 is delivered directly into the eye via an intravitreal injection, aiming to target the disease more precisely and potentially more effectively. This direct delivery method allows the drug to act where it's needed most, reducing the chance of systemic side effects. Additionally, the combination of JNJ-81201887 with a corticosteroid like triamcinolone helps prevent inflammation, which is a common issue in eye treatments. If successful, this treatment could offer a new avenue for patients who currently have limited options.

What evidence suggests that this trial's treatments could be effective for geographic atrophy?

Research has shown that JNJ-81201887 is being tested in this trial to determine if it can slow the growth of certain eye lesions, a major component of age-related macular degeneration. Participants will receive either a low or high dose of JNJ-81201887 or a sham procedure in different study arms. Early studies have assessed the treatment's safety and tolerability, paving the way for further research on its efficacy. The treatment is administered through an injection directly into the eye, aiming to deliver the medicine precisely where needed. Although specific results on JNJ-81201887's effectiveness are not yet available, this targeted approach appears promising. It could potentially slow the progression of these eye lesions, offering hope to those affected by this condition. ^{2 3 4 6 7}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

GA can be photographed in its entirety by FAF, using a 30-degree image centered on the fovea, as assessed by the CRC

Fellow eye must have a best corrected distance visual acuity (BCVA) of counting fingers or better

My eye condition is due to AMD and affects a specific area of my retina.

Exclusion Criteria

I do not have an active eye infection.

I have had laser treatment in the macula area of my eye.

I have had specific eye treatments in the area of my study eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravitreal injection of JNJ-81201887 or sham procedure, along with a 20-day oral prednisone course and a single periocular triamcinolone injection for prophylaxis of intraocular inflammation

4 weeks

1 visit (in-person) for injection, additional visits as needed for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including retinal sensitivity, visual acuity, reading speed, and functional reading independence

18 months

Regular visits (in-person) for assessments at baseline and Month 18

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-81201887
• Prednisone
• Sham Procedure
• Triamcinolone

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm B: JNJ-81201887 High dose Experimental Treatment 3 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 Dose Experimental Treatment 3 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 Procedure Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Numerous investigational agents are currently being tested for the treatment of geographic atrophy related to age-related macular degeneration, indicating a strong research interest in this area.

Despite the ongoing trials, no therapies have yet been proven effective in treating geographic atrophy, highlighting the challenges in developing successful treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for atrophic macular degeneration. Meleth, AD., Wong, WT., Chew, EY.[2022]

Various investigational drugs and therapeutic platforms are being developed to target geographic atrophy in age-related macular degeneration, focusing on different underlying causes of the disease.

As research progresses, these targeted pharmacotherapies hold promise for reducing retinal damage and preserving vision in patients affected by geographic atrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of atrophic age-related macular degeneration. Mata, NL., Vogel, R.[2010]

Citations

1.

aaojournal.org

aaojournal.org/article/S0161-6420(24)00368-3/fulltext

Phase 1 Study of JNJ-81201887 Gene Therapy in ...

To evaluate the safety and tolerability of a single intravitreal injection of JNJ-81201887 (JNJ-1887) in patients with geographic atrophy (GA) secondary to ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06635148

NCT06635148 | A Long-term Extension Study of JNJ- ...

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38909914/

Phase 1 Study of JNJ-81201887 Gene Therapy in ...

Purpose: To evaluate the safety and tolerability of a single intravitreal injection of JNJ-81201887 (JNJ-1887) in patients with geographic ...

4.

isrctn.com

isrctn.com/ISRCTN11083692

A long-term extension study of JNJ-81201887 ...

A long-term extension study of JNJ-81201887 (AAVCAGsCD59) parent studies in participants with geographic atrophy (GA) secondary to age-related macular ...

5.

jnjmedicalconnect.com

jnjmedicalconnect.com/products/jnj-81201887/medical-content/phase-1-clinical-trials

Phase 1 Clinical Trials

A phase 1, single-center, open-label, first-in-human study to assess the safety and tolerability of JNJ-1887 in patients with GA over 24 months.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06635148

NCT06635148 | A Long-term Extension Study of JNJ- ...

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 ...

7.

clinicaltrials.jnj.com

clinicaltrials.jnj.com/en/study-detail/NCT06635148

J&J Study NCT06635148

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 ...