A Prospective Multicenter, Double-Masked, Randomized, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

OTX-TKI-2020-101

Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration

2021-07-28

2023-02-06

2023-12-18

Completed

Early phase I

21

Inclusion Criteria: * Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab). * The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator. * Must have received at least 3 anti-VEGF injections in the past year. * Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit. * BCVA ETDRS score between 24 and 83 letters (\~20/25 to \~20/320 Snellen equivalent) Exclusion Criteria: * Have evidence of a scar, fibrosis or atrophy of \>50% of the total lesion in the study eye * Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments * Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3:1', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 21, 'type': 'ACTUAL'}}

2024-01-26