NCT06635148 · Janssen Research & Development, LLC
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
What this study is about
The purpose of this study is to assess the long-term safety and how well patients handle the treatment after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.
View original scientific description
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.
Interventions
DRUG
JNJ-81201887
No study intervention will be administered as part of this LTE study.
OTHER
Sham Procedure
No study intervention will be administered as part of this LTE study.
Primary outcome measures
Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)
Time frame: Upto 5 Years
Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.
Number of Participants with Abnormal Findings in Clinical Laboratory Assessments
Time frame: Upto 5 Years
Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported.
Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations
Time frame: Upto 5 Years
Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography, Color Fundus Photography) and eye examinations will be reported.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Tucson, Arizona
- Fullerton, California
- La Jolla, California
- Oxnard, California
- Pasadena, California
- Poway, California
- Walnut Creek, California
- Fort Lauderdale, Florida
- Gainesville, Florida
- Pensacola, Florida
- St. Petersburg, Florida
- Marietta, Georgia
And 31 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations