A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Conditions

• Geographic Atrophy
• Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• JNJ-81201887 — DRUG
  No study intervention will be administered as part of this LTE study.
• Sham Procedure — OTHER
  No study intervention will be administered as part of this LTE study.

Study Details

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.

Key Dates

First listed

Oct 10, 2024

Start date

Sep 19, 2024

Status verified

Sep 2026

Primary completion

Aug 24, 2029

Completion

Jul 16, 2030

Study Design

Enrollment

274 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: JNJ-81201887 Low Dose
  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.
• Experimental: Arm B: JNJ-81201887 High dose
  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.
• Sham Comparator: Arm C: Sham Procedure
  Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) will enter this LTE study. No intervention will be administered as part of this study.

Primary Outcome Measure

Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Upto 5 Years ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (45)

Find similar trials in Tucson, AZ

Related Studies

• High Resolution Retinal Imaging
  Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania
• Stem Cell Ophthalmology Treatment Study II
  Recruiting · MD Stem Cells · Westport, Connecticut
• Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
  EARLY_PHASE1 · Recruiting · MediBeacon · Ann Arbor, Michigan
• Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
  PHASE1/PHASE2 · Recruiting · National Eye Institute (NEI) · Baltimore, Maryland