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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

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

ArmDescriptionAssigned 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.
  • Drug: JNJ-81201887
    No study intervention will be administered as part of this LTE 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.
  • Drug: JNJ-81201887
    No study intervention will be administered as part of this LTE 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.
  • Other: Sham Procedure
    No study intervention will be administered as part of this LTE study.

Recruiting Locations

Retina Associates Southwest PC
Tucson, Arizona 85704

Retina Consultants of Orange County
Fullerton, California 92835

Shiley Eye Institute Jacobs Retina Center
La Jolla, California 92093 0946

California Retina Consultants
Oxnard, California 93036

California Eye Medical Specialists
Pasadena, California 91107

Retina Consultants San Diego
Poway, California 92064

Bay Area Retina Associates
Walnut Creek, California 94598

Retina Group of Florida
Fort Lauderdale, Florida 33308

VitreoRetinal Associates, PA
Gainesville, Florida 32607

Retina Specialty Institute
Pensacola, Florida 32503

Retina Vitreous Associates of Florida
St. Petersburg, Florida 33711

Georgia Retina
Marietta, Georgia 30060

Marietta Eye Clinic
Marietta, Georgia 30060

University Retina
Lemont, Illinois 60439

Midwest Eye Institute
Carmel, Indiana 46032

Maine Eye Center
Portland, Maine 04101

Retina Specialists
Baltimore, Maryland 21204

The Retina Group of Washington
Chevy Chase, Maryland 20815

Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740

Ophthalmic Consultants of Boston
Boston, Massachusetts 02114

Foundation for Vision Research
Grand Rapids, Michigan 49546

Retina Consultants of Minnesota
Saint Louis Park, Minnesota 55416

The Retina Institute
St Louis, Missouri 63128

Sierra Eye Associates
Reno, Nevada 89502

Retina-Vitreous Surgeons of Central New York
Liverpool, New York 13088

Asheville Eye Associates - Western Carolina Retinal Associates
Asheville, North Carolina 28803

Duke Eye Center
Durham, North Carolina 27705

Graystone Eye
Hickory, North Carolina 28602

NC Retina Associates
Wake Forest, North Carolina 27587

Cincinnati Eye Institute
Cincinnati, Ohio 45242

Cleveland Clinic Main Campus
Cleveland, Ohio 44195

Verum Research LLC
Eugene, Oregon 97401

Cascade Medical Research Institute, LLC
Springfield, Oregon 97477

Erie Retina Research
Erie, Pennsylvania 16505

Charleston Neuroscience Institute, LLC
Beaufort, South Carolina 29902

Austin Clinical Research
Austin, Texas 78750

Texas Retina Associates
Dallas, Texas 75231

UT Southwestern Medical Center
Dallas, Texas 75390

Retina Associates Of South Texas P A
San Antonio, Texas 78240

Retina Consultants of Texas
The Woodlands, Texas 77384

Strategic Clinical Research Group
Willow Park, Texas 76087

University of Utah
Salt Lake City, Utah 84132

Piedmont Eye Center
Lynchburg, Virginia 24502

Wagner Kapoor Research institute
Norfolk, Virginia 23502

Spokane Eye Clinical Research
Spokane, Washington 99204

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.