Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
ABI-110 Low Dose
ABI-110 High Dose
ABI-110 Medium Dose
Clinical Study ID
Ages 50-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- General:
Must be willing and able to provide written, signed informed consent.
Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informedconsentStudy eye:
Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the CentralReading Center
The macular neovascularization lesion must be confirmed as determined by theCentral Reading Center based on SD-OCT imaging at screening.
BCVA ≤ 20/32 and ≥ 20/250 (≤ 78L and ≥ 30L ETDRS letters)
History of ≥ 2 anti-VEGF injections prior to trial entry with meaningfulresponse to anti-VEGF and continued need for anti-VEGF treatment
Response to anti-VEGF at trial entry
Must be pseudophakic
Exclusion
Key Exclusion Criteria:
- Study or Fellow Eye:
Prior gene therapy, either eye
Any active ocular/intraocular infection or inflammation (e.g., blepharitis,infectious conjunctivitis, keratitis, scleritis, uveitis) or history ofidiopathic or autoimmune-associated uveitis, either eye
History of retinal disease other than wAMD or PCV, study eye
Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, orretinal epithelial tear in the center of the fovea), study eye.
History of (or active) retinal detachment, study eye
Uncontrolled glaucoma (defined as IOP > 25 mmHg despite treatment), study eye,or history of steroid-response ocular hypertension/glaucoma in either eye
History of intravitreal therapy, (other than anti-VEGF therapy) such asintravitreal steroid injection or investigational product, in the 6 monthsprior to screening, study eye
Any prior treatment with photodynamic therapy or laser photocoagulation, studyeye
History of glaucoma filtration, vitrectomy, or other procedure that couldaffect drug distribution or clearance, study eye.
Study Design
Study Description
Connect with a study center
California Retina Consultants
Bakersfield, California 93309
United StatesActive - Recruiting
Bay Area Retina Associates
Walnut Creek, California 94598
United StatesActive - Recruiting
Retina Research Institute of Texas
Abilene, Texas 79606
United StatesSite Not Available
Retina Consultants of Texas - San Antonio
San Antonio, Texas 78240
United StatesActive - Recruiting
Retina Consultants of Texas
The Woodlands, Texas 77384
United StatesActive - Recruiting
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