311 Participants Needed

JNJ-81201887 for Age-Related Macular Degeneration

Recruiting at 55 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?

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 administered in parent clinical studies.

Do I need to stop my current medications for this trial?

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

How is the drug JNJ-81201887 different from other treatments for 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, unlike other treatments that typically involve regular injections of medication into the eye to manage symptoms.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 individuals with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). Participants must have previously received JNJ-81201887 in parent studies and meet other study-specific requirements.

Inclusion Criteria

Must sign an informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations
I am not required to use birth control for this study.
I was part of a study and received treatment with JNJ-81201887 or a placebo.

Exclusion Criteria

There are no exclusion criteria for this LTE study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Long-term Extension

Participants are monitored for long-term safety and tolerability after receiving JNJ-81201887 in parent studies

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • JNJ-81201887
Trial Overview The focus of this study is on the long-term safety and effects of JNJ-81201887, which is given as an injection into the eye. The trial includes a comparison group receiving a sham procedure to evaluate differences over time.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm B: JNJ-81201887 High doseExperimental Treatment1 Intervention
Group II: Arm A: JNJ-81201887 Low DoseExperimental Treatment1 Intervention
Group III: Arm C: Sham ProcedurePlacebo Group1 Intervention

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

In a study of 80 eyes from 66 patients treated with anti-VEGF for neovascular age-related macular degeneration over 10 years, significant vision loss was observed, with best-corrected visual acuity deteriorating from 0.55 to 1.00 LogMAR (p<0.0005).
The decrease in central subfield thickness was associated with genetic risk factors, showing that patients with more risk alleles for AMD had less reduction in macular thickness, indicating a potential link between genetics and treatment outcomes.
Long-term outcome of neovascular age-related macular degeneration: association between treatment outcome and major risk alleles.Vofo, BN., Beykin, G., Levy, J., et al.[2023]
In the 24-month HARBOR study involving 1095 participants with neovascular age-related macular degeneration (AMD), new macular atrophy (MA) was detected in 29.4% of eyes that did not have baseline atrophy, indicating a significant incidence of this condition during treatment.
Despite the presence of MA, participants experienced clinically significant gains in best-corrected visual acuity (BCVA), suggesting that the benefits of ranibizumab treatment for AMD may outweigh the risks associated with MA development.
Macular Atrophy in the HARBOR Study for Neovascular Age-Related Macular Degeneration.Sadda, SR., Tuomi, LL., Ding, B., et al.[2022]
Intravitreal aflibercept (IVA) treatment in newly diagnosed neovascular age-related macular degeneration (nvAMD) showed significant improvements in best-corrected visual acuity after 3 and 6 injections, indicating its efficacy in treating this condition.
The presence of pigment epithelial detachment (PED) and serous PED at baseline negatively impacted treatment response, suggesting that these factors should be considered when evaluating potential outcomes of IVA therapy.
Aflibercept Treatment Results and Association with Baseline Characteristics in Cases of Newly Diagnosed Neovascular Age-Related Macular DegenerationKฤฑyat, P., MenteลŸ, J., Nalรงacฤฑ, S., et al.[2021]

Citations

Long-term outcome of neovascular age-related macular degeneration: association between treatment outcome and major risk alleles. [2023]
Macular Atrophy in the HARBOR Study for Neovascular Age-Related Macular Degeneration. [2022]
Aflibercept Treatment Results and Association with Baseline Characteristics in Cases of Newly Diagnosed Neovascular Age-Related Macular Degeneration [2021]
Predictive factors for non-response to intravitreal ranibizumab treatment in age-related macular degeneration. [2021]
Randomized Phase IIb Study of Brimonidine Drug Delivery System Generation 2 for Geographic Atrophy in Age-Related Macular Degeneration. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity