Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (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; Drug: Aflibercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06495918

OTX-TKI-2023-AMD-303

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: 825 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening
• Have provided written consent

Exclusion criteria

• Monocular subject or Best Corrected Visual Acuity (BCVA) score of <20 ETDRS letters or 20/400 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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825 participants in 3 patient groups

OTX-TKI Re-dose

Experimental group

Treatment:

Drug: OTX-TKI

Aflibercept 2mg on label

Active Comparator group

Treatment:

Drug: Aflibercept

Drug: Aflibercept

Aflibercept 8mg high dose

Other group

Treatment:

Drug: Aflibercept

Drug: Aflibercept