Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
Topical Steroid
RGX-314 Dose 1
RGX-314 Dose 2
Clinical Study ID
Ages 50-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age >/= 50 and </= 89
Diagnosis of CNV secondary to age-related macular degeneration in the study eye.
Participants must have demonstrated a meaningful response to anti-VEGF therapy.
Willing and able to provide written, signed informed consent for this study.
Exclusion
Exclusion Criteria:
CNV or macular edema in the study eye secondary to any causes other than AMD.
Subfoveal fibrosis or atrophy in study eye.
Participants who have had a prior vitrectomy.
Active or history of retinal detachment in the study eye.
History of intravitreal therapy in the study eye, such as intravitreal steroidinjection or investigational product (IP), other than anti-VEGF therapy, in the 6months prior to study entry.
Received any gene therapy.
Any condition preventing visualization of the fundus or VA improvement in the studyeye, eg, cataract.
History of intraocular surgery in the study eye within 12 weeks of study entry.
Receipt of any IP within 30 days of study entry or 5 half-lives of the IP.
Myocardial infarction, cerebrovascular accident, or transient ischemic attackswithin 6 months of study entry.
Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye.
COHORT 6 ONLY:
Active or history of glaucoma or ocular hypertension in the study eye.
Certain OCT characteristics including: Large Pigment Epithelial Detachments (PED), clinically significant Epiretinal Membrane (ERM) in the study eye atVisit 1.
Note: Other inclusion/exclusion criteria apply.
Study Design
Study Description
Connect with a study center
Phoenix Location
Phoenix, Arizona 85014
United StatesActive - Recruiting
Bakersfield Location
Bakersfield, California 93309
United StatesSite Not Available
Beverly Hills Location
Beverly Hills, California 90211
United StatesActive - Recruiting
Mountain View Location
Mountain View, California 94040
United StatesActive - Recruiting
Poway Location
Poway, California 92064
United StatesActive - Recruiting
Santa Barbara Location
Santa Barbara, California 93103
United StatesSite Not Available
Augusta Location
Augusta, Georgia 30909
United StatesActive - Recruiting
Baltimore Location
Baltimore, Maryland 21287
United StatesActive - Recruiting
Boston Location
Boston, Massachusetts 02114
United StatesActive - Recruiting
Reno Location
Reno, Nevada 89502
United StatesActive - Recruiting
Albuquerque Location
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
Philadelphia Location
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Germantown Location
Germantown, Tennessee 38138
United StatesSite Not Available
Nashville Location
Nashville, Tennessee 37203
United StatesSite Not Available
Woodlands Location
The Woodlands, Texas 77384
United StatesSite Not Available
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