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

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06223958

Enrollment

344

Registered

2024-01-25

Start date

2024-01-29

Completion date

2027-09-27

Last updated

2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

Neovascular Age-Related Macular Degeneration, Tyrosine Kinase Inhibitor, OTX-TKI

Brief summary

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

Interventions

DRUGOTX-TKI (axitinib implant)

Intravitreal Injection of OTX-TKI (axitinib implant)

DRUGAflibercept

Injection of 2mg (0.05mL) of aflibercept

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

1:1

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Best corrected visual acuity (BCVA)	Up to 36 Weeks	Maintenance of visual acuity, defined as \< 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss

Other

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

Countries

Argentina, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026