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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 2

Conditions: Macular Degeneration; Geographic Atrophy

Treatments: Other: Sham Procedure; Drug: JNJ-81201887

Study type: Interventional

Funder types: Industry

Identifiers

NCT06635148

81201887MDG3002

2022-500747-21-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 311 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003)
• Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study
• 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

Exclusion criteria

• There are no exclusion criteria for this LTE study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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311 participants in 3 patient groups

Arm A: JNJ-81201887 Low Dose

Experimental group

Description:

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.

Treatment:

Drug: JNJ-81201887

Arm B: JNJ-81201887 High dose

Experimental group

Description:

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.

Treatment:

Drug: JNJ-81201887

Arm C: Sham Procedure

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Procedure