A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Purpose
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.
Conditions
- Geographic Atrophy
- Macular Degeneration
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Long-term safety study of a single intravitreal dose of JNJ-81201887 administered during parent studies (81201887MDG2001: Randomized trial; 81201887MDG1003: Non-randomized trial)
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: JNJ-81201887 Low Dose |
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. |
|
|
Experimental Arm B: JNJ-81201887 High dose |
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. |
|
|
Sham Comparator Arm C: Sham Procedure |
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. |
|
Recruiting Locations
Retina Associates Southwest PC
Tucson, Arizona 85704
Tucson, Arizona 85704
Retina Consultants of Orange County
Fullerton, California 92835
Fullerton, California 92835
Shiley Eye Institute Jacobs Retina Center
La Jolla, California 92093 0946
La Jolla, California 92093 0946
California Retina Consultants
Oxnard, California 93036
Oxnard, California 93036
California Eye Medical Specialists
Pasadena, California 91107
Pasadena, California 91107
Retina Consultants San Diego
Poway, California 92064
Poway, California 92064
Bay Area Retina Associates
Walnut Creek, California 94598
Walnut Creek, California 94598
Retina Group of Florida
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
VitreoRetinal Associates, PA
Gainesville, Florida 32607
Gainesville, Florida 32607
Retina Specialty Institute
Pensacola, Florida 32503
Pensacola, Florida 32503
Retina Vitreous Associates of Florida
St. Petersburg, Florida 33711
St. Petersburg, Florida 33711
Georgia Retina
Marietta, Georgia 30060
Marietta, Georgia 30060
Marietta Eye Clinic
Marietta, Georgia 30060
Marietta, Georgia 30060
University Retina
Lemont, Illinois 60439
Lemont, Illinois 60439
Midwest Eye Institute
Carmel, Indiana 46032
Carmel, Indiana 46032
Maine Eye Center
Portland, Maine 04101
Portland, Maine 04101
Retina Specialists
Baltimore, Maryland 21204
Baltimore, Maryland 21204
The Retina Group of Washington
Chevy Chase, Maryland 20815
Chevy Chase, Maryland 20815
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
Hagerstown, Maryland 21740
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Foundation for Vision Research
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Retina Consultants of Minnesota
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
The Retina Institute
St Louis, Missouri 63128
St Louis, Missouri 63128
Sierra Eye Associates
Reno, Nevada 89502
Reno, Nevada 89502
Retina-Vitreous Surgeons of Central New York
Liverpool, New York 13088
Liverpool, New York 13088
Asheville Eye Associates - Western Carolina Retinal Associates
Asheville, North Carolina 28803
Asheville, North Carolina 28803
Duke Eye Center
Durham, North Carolina 27705
Durham, North Carolina 27705
Graystone Eye
Hickory, North Carolina 28602
Hickory, North Carolina 28602
NC Retina Associates
Wake Forest, North Carolina 27587
Wake Forest, North Carolina 27587
Cincinnati Eye Institute
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
Cleveland Clinic Main Campus
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Verum Research LLC
Eugene, Oregon 97401
Eugene, Oregon 97401
Cascade Medical Research Institute, LLC
Springfield, Oregon 97477
Springfield, Oregon 97477
Erie Retina Research
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
Charleston Neuroscience Institute, LLC
Beaufort, South Carolina 29902
Beaufort, South Carolina 29902
Austin Clinical Research
Austin, Texas 78750
Austin, Texas 78750
Texas Retina Associates
Dallas, Texas 75231
Dallas, Texas 75231
UT Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
Retina Associates Of South Texas P A
San Antonio, Texas 78240
San Antonio, Texas 78240
Retina Consultants of Texas
The Woodlands, Texas 77384
The Woodlands, Texas 77384
Strategic Clinical Research Group
Willow Park, Texas 76087
Willow Park, Texas 76087
University of Utah
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
Piedmont Eye Center
Lynchburg, Virginia 24502
Lynchburg, Virginia 24502
Wagner Kapoor Research institute
Norfolk, Virginia 23502
Norfolk, Virginia 23502
Spokane Eye Clinical Research
Spokane, Washington 99204
Spokane, Washington 99204
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC