Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocular Therapeutix, Inc.
• Treatments: Aflibercept

Criteria

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