JNJ-81201887 for Age-Related Macular Degeneration

Recruiting at 46 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

Trial Summary

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. ^{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 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

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

Treatment Details

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.

Participant Groups

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+

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

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term outcome of neovascular age-related macular degeneration: association between treatment outcome and major risk alleles. [2023]

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

Macular Atrophy in the HARBOR Study for Neovascular Age-Related Macular Degeneration. [2022]

3. Turkey pubmed.ncbi.nlm.nih.gov

Aflibercept Treatment Results and Association with Baseline Characteristics in Cases of Newly Diagnosed Neovascular Age-Related Macular Degeneration [2021]

4. England pubmed.ncbi.nlm.nih.gov

Predictive factors for non-response to intravitreal ranibizumab treatment in age-related macular degeneration. [2021]

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

Randomized Phase IIb Study of Brimonidine Drug Delivery System Generation 2 for Geographic Atrophy in Age-Related Macular Degeneration. [2023]