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

Phase 1

Completed

• Conditions: Neovascular Age-Related Macular Degeneration
• Interventions: Drug: OTX-TKI/Sham; Drug: Aflibercept/Sham

• Registration Number: NCT04989699
• Lead Sponsor: Ocular Therapeutix, Inc.

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

Study Timeline

• Study First Submitted: 2021-07-02
• Study Start: 2021-07-28
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-04
• Primary Completion: 2023-02-06
• Study Completion: 2023-12-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTX-TKI	OTX-TKI/Sham	-
Aflibercept	Aflibercept/Sham	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	Through study completion, an average of 1 year	Incidence and severity of treatment emergent adverse events

Secondary Outcome Measures

Name	Time	Method
BCVA changes	Through study completion, an average of 1 year	BCVA Changes from Baseline
Central subfield thickness changes	Through study completion, an average of 1 year	Central subfield thickness changes from baseline
Rescue Therapy	Through study completion, an average of 1 year	Proportion of subjects receiving rescue therapy
Absence of Fluid	Through study completion, an average of 1 year	Proportion of subjects with absence of foveal fluid
Number of injections	Through study completion, an average of 1 year	Number of injections from baseline

Trial Locations

Locations (1)

Ocular Therapeutix; 🇺🇸 The Woodlands, Texas, United States