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
• 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
• 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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

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