Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
AR-14034 SR implant higher dose
Sham procedure
AR-14034 SR implant lower dose
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria [Stage 1 and Stage 2]:
Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD);
Best corrected visual acuity (BCVA) between 80 and 35 letters (20/25 to 20/200 Snellen equivalent) in the study eye;
BCVA greater than 34 letters (approximately 20/200 Snellen equivalent) in the non-study eye;
Media clarity and pupillary dilation in the study eye sufficient for all planned study procedures;
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;
Other protocol-specified inclusion criteria may apply.
[Stage 1]:
- Greater than or equal to 3 and less than or equal to 6 prior treatments of an ocular anti-VEGF medication within the 8 months prior to Screening in the study eye, with demonstrated anatomic response, as assessed by the Investigator.
[Stage 2]:
- Treatment-naïve, or initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye within 9 months before Screening.
Key Exclusion Criteria [Stage 1 and Stage 2]:
History or current ocular disease in the study eye other than nAMD, that, might require medical or surgical intervention during the study;
Structural damage to the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the nAMD;
Any active intraocular or periocular infection or active intraocular inflammation;
Treatment with ocular anti-VEGF product within 28-days before Week -1 [Stage 1] or Baseline [Stage 2];
Uncontrolled glaucoma in the study eye;
Uncontrolled blood pressure;
Females of child-bearing potential who are pregnant, intending to become pregnant, nursing, or who are not willing to use an acceptable form of contraception for the duration of the study;
Other protocol-specified exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Emanuelli Research and Development Center, LLC
Arecibo, 00612
Puerto RicoActive - Recruiting
Trinity Research Group
Dothan, Alabama 36301
United StatesActive - Recruiting
Associated Retina Consultants - Gilbert
Gilbert, Arizona 85297
United StatesActive - Recruiting
Associated Retina Consultants - Phoenix
Phoenix, Arizona 85020
United StatesActive - Recruiting
Retina Associates of SW PC
Tucson, Arizona 85704
United StatesActive - Recruiting
Retina Associates of Orange County
Laguna Hills, California 92653
United StatesActive - Recruiting
Northern California Retina Vitreous Associates Medical Group
Mountain View, California 94040
United StatesActive - Recruiting
Retinal Consultants Medical Group, Inc.
Sacramento, California 95825
United StatesActive - Recruiting
Retina Consultants of Southern Colorado
Colorado Springs, Colorado 80809
United StatesActive - Recruiting
Blue Ocean Clinical Research Center
Clearwater, Florida 33761
United StatesActive - Recruiting
Florida Retina Institute
Orlando, Florida 32806
United StatesActive - Recruiting
Retina Specialty Institute
Pensacola, Florida 32503
United StatesActive - Recruiting
Eye Associates of Pinellas
Pinellas Park, Florida 33782
United StatesActive - Recruiting
Retina Vitreous Associates of Florida
Saint Petersburg, Florida 33711
United StatesSite Not Available
Center for Retina and Macular Disease
Winter Haven, Florida 33880
United StatesActive - Recruiting
Thomas Eye Group
Sandy Springs, Georgia 30328
United StatesActive - Recruiting
University Retina and Macula Associates, PC
Oak Forest, Illinois 60452
United StatesActive - Recruiting
Cumberland Valley Retina Consultants, PC
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Twin Cities Eye Consultants
Coon Rapids, Minnesota 55433
United StatesActive - Recruiting
Sierra Eye Associates
Reno, Nevada 89502
United StatesActive - Recruiting
Verum Research, LLC
Eugene, Oregon 97401
United StatesActive - Recruiting
Erie Retina Research
Erie, Pennsylvania 16507
United StatesActive - Recruiting
MidAtlantic Retina Research
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Retina Consultants of Carolina
Greenville, South Carolina 29605
United StatesActive - Recruiting
Carolina Eyecare Physicians LLC
Mount Pleasant, South Carolina 29464
United StatesActive - Recruiting
Retina Research Institute of Texas
Abilene, Texas 79606
United StatesActive - Recruiting
Texas Retina Associates
Arlington, Texas 76102
United StatesActive - Recruiting
Austin Clinical Research, LLC
Austin, Texas 78750
United StatesActive - Recruiting
Austin Research Center for Retina
Austin, Texas 78705
United StatesActive - Recruiting
Texas Retina Associates
Dallas, Texas 75231
United StatesActive - Recruiting
Medical Center Ophthalmology Associates
San Antonio, Texas 78240
United StatesActive - Recruiting
Retina Consultants of Texas - San Antonio
San Antonio, Texas 78251
United StatesActive - Recruiting
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