JNJ-81201887 for Age-Related Macular Degeneration

Phase 2

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upto 5 years

Summary

This trial aims to check the safety and how well people can tolerate JNJ-81201887 after getting a shot in the eye, based on previous studies. "This trial aims to assess the long

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, changes in vision, eye inflammation or infection, and possible systemic effects due to medication absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was part of a study and received treatment with JNJ-81201887 or a placebo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upto 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upto 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Abnormal Findings in Clinical Laboratory Assessments

Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations

Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm B: JNJ-81201887 High doseExperimental Treatment1 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 DoseExperimental Treatment1 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 ProcedurePlacebo Group1 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.

0 / 1Eligibility criteria met