305 Participants Needed

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

Recruiting at 179 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

JR

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
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
See 2 more

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.
See 2 more

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?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm B: JNJ-81201887 High doseExperimental Treatment3 Interventions
Group II: Arm A: JNJ-81201887 Low DoseExperimental Treatment3 Interventions
Group III: Arm C: Sham ProcedurePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

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 profile image

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

Citations

Treatment for atrophic macular degeneration. [2022]
Prevalence and Genetic Characteristics of Geographic Atrophy among Elderly Japanese with Age-Related Macular Degeneration. [2022]
GEOGRAPHIC ATROPHY INCIDENCE AND PROGRESSION AFTER INTRAVITREAL INJECTIONS OF ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR AGENTS FOR AGE-RELATED MACULAR DEGENERATION: A Meta-Analysis. [2023]
Pharmacologic treatment of atrophic age-related macular degeneration. [2010]
Emerging treatments for geographic atrophy in age-related macular degeneration. [2023]
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