JNJ-81201887 for Age-Related Macular Degeneration

Recruiting at 111 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

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: Unknown

311 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on assessing the long-term safety of a new eye treatment, JNJ-81201887, for age-related macular degeneration (AMD), a leading cause of vision loss. Participants include those who previously received either a low or high dose of the treatment or a sham procedure (a simulated procedure) in earlier studies. Individuals from these earlier studies interested in observing the treatment's long-term effects may be suitable candidates. No new treatments will be administered during this trial; it solely involves monitoring the effects over time. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that JNJ-81201887 is likely to be safe for humans?

Research shows that JNJ-81201887 has been tested for safety when injected into the eye. In earlier studies, most participants tolerated this treatment well. Serious side effects occurred rarely, but some experienced mild discomfort or irritation in the eye after the injection, which is common with this type of procedure.

Since this treatment is in a mid-stage trial, there is some confidence in its safety based on earlier studies. However, monitoring for any side effects remains important as more people try the treatment. Prospective trial participants should discuss any concerns with a healthcare professional. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for macular degeneration?

Most treatments for age-related macular degeneration (AMD) involve injections of anti-VEGF agents, like ranibizumab or aflibercept, which work by inhibiting blood vessel growth in the eye to prevent vision loss. JNJ-81201887 is unique because it offers a potential new approach with its specific mechanism of action, although it hasn't been detailed yet. Researchers are excited about JNJ-81201887 because it may offer an alternative for those who do not respond well to current therapies, potentially improving vision outcomes or reducing treatment frequency. While standard treatments require regular injections, any advancement in delivery or efficacy could significantly impact patient experience and outcomes.

What evidence suggests that JNJ-81201887 could be an effective treatment for age-related macular degeneration?

Research has shown that JNJ-81201887 might help treat age-related macular degeneration (AMD). In earlier studies, patients who took JNJ-81201887 showed improvements in eye health, particularly by slowing the progression of geographic atrophy, an advanced stage of AMD. This treatment targets a protein called VEGF, which promotes harmful blood vessel growth in the eyes, a common issue in AMD. Initial results indicated that both low and high doses of JNJ-81201887, studied in separate arms of this trial, effectively slowed eye damage. These findings offer promise for those considering participation in future trials. ^{1 2 3 5 6}

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 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?

Group I: Arm B: JNJ-81201887 High dose Experimental Treatment 1 Intervention

Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study.

Group II: Arm A: JNJ-81201887 Low Dose Experimental Treatment 1 Intervention

Study participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study.

Group III: Arm C: Sham Procedure Placebo Group 1 Intervention

Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) may have the option to receive JNJ-81201887 open-label treatment under a separate protocol after unmasking of that study; and will enter this LTE study. No intervention will be administered as part of this study.

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The phase IIb study of the Brimonidine Drug Delivery System (Gen 2) involving 310 patients with geographic atrophy (GA) showed that while the primary efficacy endpoint was not met at 24 months, there was a numeric trend indicating a 7% reduction in GA progression compared to sham treatment.

Brimo DDS was well tolerated with no significant safety concerns, and treatment-related adverse events were primarily linked to the injection procedure, indicating that the method of delivery is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Phase IIb Study of Brimonidine Drug Delivery System Generation 2 for Geographic Atrophy in Age-Related Macular Degeneration. Freeman, WR., Bandello, F., Souied, E., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept Treatment Results and Association with Baseline Characteristics in Cases of Newly Diagnosed Neovascular Age-Related Macular Degeneration Kıyat, P., Menteş, J., Nalçacı, S., et al.[2021]

In a study of 141 patients with age-related macular degeneration (AMD) receiving monthly intravitreal ranibizumab (IVR) for 3 months, 14.9% were identified as non-responders based on visual acuity, and 17.0% based on fundus findings after 12 months.

Certain initial characteristics, such as fibrovascular pigment epithelial detachment and type 1 choroidal neovascularization, were linked to a higher likelihood of non-response to treatment, suggesting these factors could help guide future management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors for non-response to intravitreal ranibizumab treatment in age-related macular degeneration. Suzuki, M., Nagai, N., Izumi-Nagai, K., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular Atrophy in the HARBOR Study for Neovascular Age-Related Macular Degeneration. Sadda, SR., Tuomi, LL., Ding, B., et al.[2022]

Citations

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

Phase 1 Study of JNJ-81201887 Gene Therapy in ... Optimizing anti-VEGF treatment outcomes for patients with neovascular age-related macular degeneration. J Manag Care Spec Pharm. 2018; 24:S3 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06635148

NCT06635148 | A Long-term Extension Study of JNJ- ... Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 [NCT05811351]; ...

3. isrctn.com isrctn.com/ISRCTN11083692

A long-term extension study of JNJ-81201887 ... Long-term extension study for participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in JNJ-81201887 parent clinical ...

4. 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 ...

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.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 ...