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Clinical Trials/CTRI/2025/04/085831
CTRI/2025/04/085831
Recruiting
Phase 3

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

Ocular Therapeutix, Inc.20 sites in 1 country825 target enrollmentStarted: May 9, 2025Last updated:
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Overview

Phase
Phase 3
Status
Recruiting
Enrollment
825
Locations
20
Primary Endpoint
Mean change in best corrected visual acuity (BCVA)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study consists of a 24-week screening and run-in period prior to Day 1,

followed by an active study treatment period from Day 1 to Week 40 (Visit 17),

with a follow-up period through Week 48 (Visit 19). The primary analysis is at

Week 48.

Study Design

Study Type
Interventional
Allocation
Randomized

Eligibility Criteria

Ages
50.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Subjects with a diagnosis of active macular choroidal neovascularization (MNV) secondary to nAMD, who are at least 50 years of age, whose study eye either is treatment naive, or was diagnosed with nAMD within 4 months prior to screening and received 1 to 3 consecutive monthly (approximately every 4 weeks) anti-VEGF injections (except Beovu®) prior to Screening.

Exclusion Criteria

  • •Presence of a disease other than CNV due to AMD in the study eye that could affect vision or safety assessments.

Outcomes

Primary Outcomes

Mean change in best corrected visual acuity (BCVA)

Time Frame: Change from baseline to Week 48

Secondary Outcomes

  • Change in letters on ETDRS at Week 48(Week 48)

Investigators

Sponsor Class
Pharmaceutical industry-Global
Responsible Party
Principal Investigator
Principal Investigator

Dr Saurendra Das

PFC Pharma Focus India Pvt Ltd

Study Sites (20)

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