Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration

Phase 3Active Not RecruitingNCT06223958

Ocular Therapeutix, Inc.344 enrolled

Overview

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

344

Conditions

Neovascular Age-Related Macular Degeneration

Interventions

OTX-TKI (axitinib implant)DRUG

Intravitreal Injection of OTX-TKI (axitinib implant)

AfliberceptDRUG

Injection of 2mg (0.05mL) of aflibercept

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Treatment naïve for Neovascular Age-Related Macular Degeneration (nAMD) in either eye at screening. * Are at least older than 50 years of age at Day 1. * Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDRS letters of Best Corrected Visual Acuity (BCVA) from Screening (Visit 1) BCVA Exclusion Criteria: * Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 in fellow eye at screening. * Have evidence of a scar, fibrosis, or atrophy of \> 50% of the total lesion in the study eye.

Locations (108)

Outcomes

Primary Outcomes

Best corrected visual acuity (BCVA)

Maintenance of visual acuity, defined as \< 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss

Time frame: Up to 36 Weeks

Data from ClinicalTrials.gov

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