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

Phase 3

Active, not recruiting

• Conditions: Neovascular Age-Related Macular Degeneration
• Interventions: Drug: OTX-TKI (axitinib implant); Drug: Aflibercept

• Registration Number: NCT06223958
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-01-25
• Study Start: 2024-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-04-29
• Study Completion: 2027-09-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 344

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTX-TKI (axitinib implant)	OTX-TKI (axitinib implant)	-
Control	Aflibercept	-

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA)	Up to 36 Weeks	Maintenance of visual acuity, defined as \< 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss

Trial Locations

Locations (105)

Retina Associates of Cleveland, Inc. - Beachwood; 🇺🇸 Beachwood, Ohio, United States

SC CNI Retina Consultants of Charleston; 🇺🇸 Beaufort, South Carolina, United States

Associated Retina Consultants - Gilbert; 🇺🇸 Gilbert, Arizona, United States

Associated Retina Consultants - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Retinal Research Institute; 🇺🇸 Phoenix, Arizona, United States

Retina Macula Institute of Arizona; 🇺🇸 Scottsdale, Arizona, United States

CA CRC California Retina Consultants; 🇺🇸 Oxnard, California, United States

The Retina Partners - Encino; 🇺🇸 Encino, California, United States

Retina Consultants of Orange County - Fullerton; 🇺🇸 Fullerton, California, United States

Atlantis Eyecare; 🇺🇸 Huntington Beach, California, United States

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