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

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: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2026-04-29
• Study Completion: 2027-09-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

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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.

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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 (56)

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

CA RCMG Retinal Consultants Medical Group, Inc.; 🇺🇸 Modesto, California, United States

AzulVision; 🇺🇸 Pasadena, California, United States

Bay Area Retina Associates, A Medical Group; 🇺🇸 Walnut Creek, California, United States

Retina Vitreous Associates of Florida (RVA) - Saint Petersburg; 🇺🇸 Saint Petersburg, Florida, United States

Florida Retina Consultants - Lakeland; 🇺🇸 Lakeland, Florida, United States

Retina Specialty Institute - Pensacola; 🇺🇸 Pensacola, Florida, United States

University Retina and Macula Associates, P.C.; 🇺🇸 Oak Forest, Illinois, United States

Wolfe Eye Clinic; 🇺🇸 West Des Moines, Iowa, United States

Retina Research Institute, LLC; 🇺🇸 Saint Louis, Missouri, United States

Retina-Vitreous Surgeons of Central New York; 🇺🇸 Liverpool, New York, United States

The Retina Center Of New Jersey, LLC - Bloomfield; 🇺🇸 Bloomfield, New Jersey, United States

Erie Retina Research; 🇺🇸 Erie, Pennsylvania, United States

Palmetto Retina Center; 🇺🇸 West Columbia, South Carolina, United States

Black Hills Regional Eye Institute (BHREI); 🇺🇸 Rapid City, South Dakota, United States

Charles Retina Institute PC; 🇺🇸 Germantown, Tennessee, United States

West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA); 🇺🇸 Abilene, Texas, United States

Retina Consultants of Austin PA (RCA) - Central Austin; 🇺🇸 Austin, Texas, United States

Austin Retina Associates, PLLC; 🇺🇸 Austin, Texas, United States

Retina Research Center (RRC); 🇺🇸 Austin, Texas, United States

Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas); 🇺🇸 Bellaire, Texas, United States

Wagner Macula & Retina Center - Norfolk, VA Office; 🇺🇸 Norfolk, Virginia, United States

Emanuelli research and development; 🇵🇷 Arecibo, Puerto Rico

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

Retina-Vitreous Associates Medical Group - Los Angeles; 🇺🇸 Los Angeles, California, United States

CA CRC California Retina Consultants; 🇺🇸 Santa Barbara, California, United States

Macula Retina Vitreous Center; 🇺🇸 Torrance, California, United States

The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC); 🇺🇸 Clearwater, Florida, United States

Rand Eye Institute; 🇺🇸 Deerfield Beach, Florida, United States

Retina Group of Florida - Fort Lauderdale; 🇺🇸 Fort Lauderdale, Florida, United States

Southeast Retina Center, P.C. - Augusta; 🇺🇸 Augusta, Georgia, United States

Illinois Retina Associates, S.C. - Lincoln Park; 🇺🇸 Chicago, Illinois, United States

IN AVRUC Associated Vitreoretinal and Uveitis Consultants; 🇺🇸 Carmel, Indiana, United States

Mid Atlantic Retina Specialists - Hagerstown; 🇺🇸 Hagerstown, Maryland, United States

Cumberland Valley Retina Consultants; 🇺🇸 Hagerstown, Maryland, United States

Mississippi Baptist Medical Center; 🇺🇸 Jackson, Mississippi, United States

Sierra Eye Associates; 🇺🇸 Reno, Nevada, United States

Asheville Eye Associates (AEA) - Retinal Office; 🇺🇸 Asheville, North Carolina, United States

Charleston Neuroscience Institute; 🇺🇸 Ladson, South Carolina, United States

Texas Retina Associates (TRA) - Arlington; 🇺🇸 Arlington, Texas, United States

Retina Consultants of Houston; 🇺🇸 The Woodlands, Texas, United States

Retina Partners Midwest; 🇺🇸 Indianapolis, Indiana, United States

Maine Eye Center - Marginal Way Campus; 🇺🇸 Portland, Maine, United States

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

RSC Research, PLLC; 🇺🇸 Denver, Colorado, United States

Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location; 🇺🇸 Nashville, Tennessee, United States

Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location; 🇺🇸 San Antonio, Texas, United States

TX RCTX Retina Consultants of Texas; 🇺🇸 San Antonio, Texas, United States

Retina Associates of Utah, P.C - Intermountain Medical Center Location; 🇺🇸 Salt Lake City, Utah, United States

Pepose Vision Institute; 🇺🇸 Chesterfield, Missouri, United States

Retina Consultants of Minnesota; 🇺🇸 Edina, Minnesota, United States

California Retina Consultants (CRC) - Santa Barbara; 🇺🇸 Santa Barbara, California, United States

Retina Group of New England, PC; 🇺🇸 Waterford, Connecticut, United States

Vistar Eye Center Vision and Surgery Specialists; 🇺🇸 Roanoke, Virginia, United States

Florida Retina Institute - Lake Mary; 🇺🇸 Lake Mary, Florida, United States

Keystone Research; 🇺🇸 Austin, Texas, United States