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

Recruiting at 179 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

305 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the drug JNJ-81201887 different from other treatments for geographic atrophy in age-related macular degeneration?

JNJ-81201887 is unique because it uses gene therapy to deliver a protein that may help protect the eye from damage, which is different from other treatments that often focus on reducing blood vessel growth. This approach aims to slow down the progression of vision loss in geographic atrophy. ^{1 2 3 4 5}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

One of my eye lesions is larger than 1.25 mm^2.

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

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

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

Treatment Details

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.

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment for atrophic macular degeneration. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prevalence and Genetic Characteristics of Geographic Atrophy among Elderly Japanese with Age-Related Macular Degeneration. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

GEOGRAPHIC ATROPHY INCIDENCE AND PROGRESSION AFTER INTRAVITREAL INJECTIONS OF ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR AGENTS FOR AGE-RELATED MACULAR DEGENERATION: A Meta-Analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of atrophic age-related macular degeneration. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Emerging treatments for geographic atrophy in age-related macular degeneration. [2023]