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

Ocular Therapeutix

Status and phase: Enrolling; Phase 3

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Drug: OTX-TKI (axitinib implant); Drug: Aflibercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06223958

SOL-1 (Other Identifier)

OTX-TKI-2023-AMD-301

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

OTX-TKI (axitinib implant)

Experimental group

Treatment:

Drug: OTX-TKI (axitinib implant)

Control

Other group

Treatment:

Drug: Aflibercept