Long-term safety assessment of JNJ-81201887 for eye condition related to aging
Long-term Extension Study for Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies
This study is testing the long-term safety of a new eye treatment for age-related vision loss in people who have already tried it before.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 274 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Locations | 104 sites (Tucson, Arizona and 103 other locations) |
| Trial ID | NCT06635148 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term safety and tolerability of JNJ-81201887, an investigational treatment administered via intravitreal injection, in participants who previously received this treatment or a sham in earlier clinical studies. The study aims to gather data on the effects of the treatment over an extended period. Participants will be monitored for any adverse effects and overall health outcomes related to geographic atrophy secondary to age-related macular degeneration.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in parent studies and received treatment with JNJ-81201887 or a sham procedure.
Not a fit: Patients who have not participated in the parent studies will not benefit from this long-term extension study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety of a new treatment for patients with geographic atrophy.
How similar studies have performed: Other studies involving similar treatments for age-related macular degeneration have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tucson, Arizona and 103 other locations
- Retina Associates Southwest PC — Tucson, Arizona, United States (Recruiting)
- Retina Consultants of Orange County — Fullerton, California, United States (Recruiting)
- Shiley Eye Institute Jacobs Retina Center — La Jolla, California, United States (Recruiting)
- California Retina Consultants — Oxnard, California, United States (Recruiting)
- California Eye Medical Specialists — Pasadena, California, United States (Recruiting)
- Retina Consultants San Diego — Poway, California, United States (Recruiting)
- Bay Area Retina Associates — Walnut Creek, California, United States (Recruiting)
- Retina Group of Florida — Fort Lauderdale, Florida, United States (Recruiting)
- VitreoRetinal Associates, PA — Gainesville, Florida, United States (Recruiting)
- Retina Specialty Institute — Pensacola, Florida, United States (Recruiting)
- Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States (Recruiting)
- Georgia Retina — Marietta, Georgia, United States (Recruiting)
- Marietta Eye Clinic — Marietta, Georgia, United States (Recruiting)
- University Retina — Lemont, Illinois, United States (Recruiting)
- Midwest Eye Institute — Carmel, Indiana, United States (Recruiting)
- Maine Eye Center — Portland, Maine, United States (Recruiting)
- Retina Specialists — Baltimore, Maryland, United States (Recruiting)
- The Retina Group of Washington — Chevy Chase, Maryland, United States (Recruiting)
- Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States (Recruiting)
- Ophthalmic Consultants of Boston — Boston, Massachusetts, United States (Recruiting)
- Foundation for Vision Research — Grand Rapids, Michigan, United States (Recruiting)
- Retina Consultants of Minnesota — Saint Louis Park, Minnesota, United States (Recruiting)
- The Retina Institute — St Louis, Missouri, United States (Recruiting)
- Sierra Eye Associates — Reno, Nevada, United States (Recruiting)
- Retina-Vitreous Surgeons of Central New York — Liverpool, New York, United States (Recruiting)
- Asheville Eye Associates - Western Carolina Retinal Associates — Asheville, North Carolina, United States (Recruiting)
- Duke Eye Center — Durham, North Carolina, United States (Recruiting)
- Graystone Eye — Hickory, North Carolina, United States (Recruiting)
- NC Retina Associates — Wake Forest, North Carolina, United States (Recruiting)
- Cincinnati Eye Institute — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic Main Campus — Cleveland, Ohio, United States (Recruiting)
- Verum Research LLC — Eugene, Oregon, United States (Recruiting)
- Cascade Medical Research Institute, LLC — Springfield, Oregon, United States (Recruiting)
- Erie Retina Research — Erie, Pennsylvania, United States (Recruiting)
- Charleston Neuroscience Institute, LLC — Beaufort, South Carolina, United States (Recruiting)
- Austin Clinical Research — Austin, Texas, United States (Recruiting)
- Texas Retina Associates — Dallas, Texas, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Retina Associates Of South Texas P A — San Antonio, Texas, United States (Recruiting)
- Retina Consultants of Texas — The Woodlands, Texas, United States (Recruiting)
- Strategic Clinical Research Group — Willow Park, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Piedmont Eye Center — Lynchburg, Virginia, United States (Recruiting)
- Wagner Kapoor Research institute — Norfolk, Virginia, United States (Recruiting)
- Spokane Eye Clinical Research — Spokane, Washington, United States (Recruiting)
- Centre for Eye Research Australia — East Melbourne, Australia (Recruiting)
- Strathfield Retina Clinic — Strathfield, Australia (Recruiting)
- Sydney Retina Clinic and Day Surgery — Sydney, Australia (Recruiting)
- Sydney West Retina — Westmead, Australia (Recruiting)
- Ziekenhuis Oost-Limburg — Genk, Belgium (Recruiting)
+54 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.