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NCT06223958 Clinical Trial

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

Neovascular Age-Related Macular Degeneration Clinical Trial

Official title:
A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06223958
Other study ID # OTX-TKI-2023-AMD-301
Secondary ID SOL-1
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 29, 2024
Est. completion date September 27, 2027

Study information
Verified date February 2024
Source Ocular Therapeutix, Inc.
Contact Clinical Project Manager
Phone 781-357-4000
Email clinicalaffairs@ocutx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date September 27, 2027
Est. primary completion date April 29, 2026
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• OTX-TKI (axitinib implant)
Intravitreal Injection of OTX-TKI (axitinib implant)
• Aflibercept
Injection of 2mg (0.05mL) of aflibercept

Locations
Country Name City State
United States Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas) Bellaire Texas
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Sierra Eye Associates Reno Nevada
United States California Retina Consultants (CRC) - Santa Barbara Santa Barbara California
United States Retina Consultants of Houston The Woodlands Texas

Sponsors (3)
Lead Sponsor Collaborator
Ocular Therapeutix, Inc. Duke University, Fortrea

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Incidence and severity of treatment emergent adverse events (AEs) Changes Safety Outcomes from Baseline Up to 104 Weeks
Primary 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 Up to 36 Weeks
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