Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
ABBV-RGX-314 Dose 1
ABBV-RGX-314 Dose 4
ABBV-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 AND 7 ONLY:
Active or history of glaucoma or ocular hypertension (steroid-induced ocularhypertension (Cohort 7 only)) in the study eye.
Certain OCT characteristics including: Large Pigment Epithelial Detachments (PED),clinically significant Epiretinal Membrane (ERM) in the study eye at Visit 1.
Note: Other inclusion/exclusion criteria apply.
Study Design
Study Description
Connect with a study center
Phoenix Location
Phoenix, Arizona 85014
United StatesSite Not Available
Retinal Research Institute /ID# 255925
Phoenix 5308655, Arizona 5551752 85053
United StatesSite Not Available
Bakersfield Location
Bakersfield, California 93309
United StatesSite Not Available
Beverly Hills Location
Beverly Hills, California 90211
United StatesSite Not Available
Mountain View Location
Mountain View, California 94040
United StatesSite Not Available
Poway Location
Poway, California 92064
United StatesSite Not Available
Santa Barbara Location
Santa Barbara, California 93103
United StatesSite Not Available
California Retina Consultants - Bakersfield /ID# 255910
Bakersfield 5325738, California 5332921 93309-1677
United StatesSite Not Available
Retina Vitreous Assoc Med Grp /ID# 255921
Beverly Hills 5328041, California 5332921 90211
United StatesSite Not Available
Retinal Diagnostic Center /ID# 272275
Campbell 5333689, California 5332921 95008
United StatesSite Not Available
Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920
Mountain View 5375480, California 5332921 94040-4101
United StatesSite Not Available
Retina Consultants of San Diego /ID# 255911
Poway 5384690, California 5332921 92064-2530
United StatesSite Not Available
California Retina Consultants - Santa Barbara /ID# 255923
Santa Barbara 5392952, California 5332921 93103
United StatesSite Not Available
Augusta Location
Augusta, Georgia 30909
United StatesSite Not Available
Southeast Retina Center /ID# 255912
Augusta 4180531, Georgia 4197000 30909
United StatesSite Not Available
Springfield Clinic - First /ID# 272274
Springfield 4250542, Illinois 4896861 62702
United StatesSite Not Available
Baltimore Location
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins Hospital /ID# 255919
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
Boston Location
Boston, Massachusetts 02114
United StatesSite Not Available
Ophthalmic Consultants of Boston /ID# 255917
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Reno Location
Reno, Nevada 89502
United StatesSite Not Available
Sierra Eye Associates /ID# 255908
Reno 5511077, Nevada 5509151 89502
United StatesSite Not Available
Albuquerque Location
Albuquerque, New Mexico 87109
United StatesSite Not Available
Eye Associates of New Mexico /ID# 255915
Albuquerque 5454711, New Mexico 5481136 87109
United StatesSite Not Available
Duke University Medical Center /ID# 267646
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Philadelphia Location
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Mid Atlantic Retina /ID# 255906
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
Germantown Location
Germantown, Tennessee 38138
United StatesSite Not Available
Nashville Location
Nashville, Tennessee 37203
United StatesSite Not Available
Charles Retina Institute /ID# 255922
Germantown 4624601, Tennessee 4662168 38138
United StatesSite Not Available
Tennessee Retina - Nashville /ID# 255918
Nashville 4644585, Tennessee 4662168 37203-1513
United StatesSite Not Available
Woodlands Location
The Woodlands, Texas 77384
United StatesSite Not Available
Retina Consultants - The Woodlands /ID# 255924
The Woodlands 4736476, Texas 4736286 77384
United StatesSite Not Available

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