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)

Ocular Therapeutix, Inc.1 site in 1 country21 target enrollmentJuly 28, 2021

ConditionsNeovascular Age-Related Macular Degeneration

InterventionsOTX-TKI/Sham Aflibercept/Sham

DrugsOTX-TKI/Sham Aflibercept/Sham

Overview

Phase: Phase 1
Intervention: OTX-TKI/Sham
Conditions: Neovascular Age-Related Macular Degeneration
Sponsor: Ocular Therapeutix, Inc.
Enrollment: 21
Locations: 1
Primary Endpoint: Safety and Tolerability
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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

Registry

clinicaltrials.gov

Start Date

July 28, 2021

End Date

December 18, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ocular Therapeutix, Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

OTX-TKI

Intervention: OTX-TKI/Sham

Aflibercept

Intervention: Aflibercept/Sham

Outcomes

Primary Outcomes

Safety and Tolerability

Time Frame: Through study completion, an average of 1 year

Incidence and severity of treatment emergent adverse events

Secondary Outcomes

BCVA changes(Through study completion, an average of 1 year)
Central subfield thickness changes(Through study completion, an average of 1 year)
Rescue Therapy(Through study completion, an average of 1 year)
Absence of Fluid(Through study completion, an average of 1 year)
Number of injections(Through study completion, an average of 1 year)