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

Ocular Therapeutix

Status and phase

Completed

Phase 1

Conditions

Neovascular Age-Related Macular Degeneration

Treatments

Drug: OTX-TKI/Sham

Drug: Aflibercept/Sham

Study type

Interventional

Funder types

Industry

Identifiers

NCT04989699

OTX-TKI-2020-101

Details and patient eligibility

About

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

Full description

Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration

Enrollment

21 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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