A long-term extension study of JNJ-81201887 (AAVCAGsCD59) parent studies in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

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

Registry ID
ISRCTN11083692
Source registry
ISRCTN
Status
No longer recruiting
Phase
PHASE2
Study type
INTERVENTIONAL
Sponsor
Janssen-Cilag International N.V.
Enrollment
311
Start date
2024-09-19
Completion date
2029-08-29
Last update
2026-08-17

Conditions

Summary

Geographic Atrophy, secondary to age-related macular degeneration

Detailed 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. 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. Participants randomised 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 that study and will enter this LTE study. No intervention will be administered as part of this study.

Interventions

Inclusion criteria

1. Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003) 2. Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study 3. 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

Locations

Related clinical trials

View on source registry