RecruitingPhase 2

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

United States274 participantsStarted 2024-09-19

Plain-language summary

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.

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Upto 5 Years

Number of Participants with Abnormal Findings in Clinical Laboratory Assessments

Timeframe: Upto 5 Years

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

Timeframe: Upto 5 Years

Trial details

NCT IDNCT06635148

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-08-24

Contact for this trial

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

View on ClinicalTrials.gov More Geographic Atrophy trials