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 logo

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

300 participants in 2 patient groups

OTX-TKI (axitinib implant)
Experimental group
Treatment:
Drug: OTX-TKI (axitinib implant)
Control
Other group
Treatment:
Drug: Aflibercept

Trial contacts and locations

5

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Central trial contact

Nichole Wilkes; Clinical Project Manager

Data sourced from clinicaltrials.gov

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