Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
HG202
Clinical Study ID
Ages 50-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females ≥ 50 and ≤ 80 years at the time of signing the ICF
Diagnosed of choroidal neovascularization (CNV) secondary to AMD in the study eye;
Best-corrected visual acuity (BCVA) ranged from 73 to 23 early treatment diabeticretinopathy study (ETDRS)letter score (corresponding to 20/32 to 20/320 of Snellenvisual acuity) in the study eye;
BCVA in the non-study eye had an ETDRS letter score of 19(equivalent to Snellenvisual acuity20/400) and above;
Able to perform visual acuity and retinal function tests and able and willing tocomply with study procedures for this clinical trial;
RESPONSIVE SUBJECTS:
- History of need for and responsive to anti-VEGF therapy in the study eye
NON-RESPONSIVE SUBJECTS:
- History of receiving anti-VEGF therapy but is resistant to treatment, which isdefined as: a. complete or near-complete remission of subretinal fluid after theinitial 3 doses of anti-VEGF agents and thenno improvement (less than 50umreduction) or deterioration of CRT by OCT
Exclusion
Exclusion Criteria:
Subretinal hemorrhage, scarring, or fibrosis of greater than 50% of the total lesionin the study eye;
Any condition in the Investigator's opinion that could limit visual improvement inthe study eye;
Other ocular diseases that may affect central vision in the study eye (e.g., retinalvein occlusion, retinal detachment, macular hole, optic nerve disease, etc.);
Presence of CNV not due to nAMD in the study eye,
Uncontrolled glaucoma in the study eye;
Active intraocular inflammation or a history of uveitis in either eye;
History or presence of corneal dystrophy in the study eye;
Subjects with immunodeficiency diseases prone to opportunistic infections;
History of other intraocular surgery in the study eye within 3 months prior tobaseline that in the Investigator's opinion could impact healing or study outcomeinterpretation;
Prior gene therapy or oligonucleotide therapy;
History of acute coronary syndrome, myocardial infarction, coronaryrevascularization, cerebrovascular accident, or transient ischemic attack within 6months prior to the Screening Visit;
Other conditions judged by the investigator as inappropriate for the study.
Study Design
Connect with a study center
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai
ChinaActive - Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjing
ChinaActive - Recruiting
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