NCT07516132RecruitingPhase 3
A Phase 3b, Multicenter, Open-Label, Extension Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study
Ocular Therapeutix, Inc.8 sites in 1 country850 target enrollmentStarted: April 27, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Ocular Therapeutix, Inc.
- Enrollment
- 850
- Locations
- 8
- Primary Endpoint
- Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144
Study Overview
Brief Summary
Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96
- •Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging
- •Are able and willing to comply with all study requirements and visits
- •Have provided written informed consent
Exclusion Criteria
- •Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1
- •History of intraocular inflammation in the study eye
- •Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular
- •Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results
- •Female participants who are pregnant (had a positive urine test at the Baseline visit [Day 1]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.
Outcomes
Primary Outcomes
Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144
Time Frame: from Baseline (Day 1) through Week 144
Number of events
Proportion of participants with severe vision loss (defined as ≥ 30 Early Treatment Diabetic Retinopathy Study [ETDRS] letters loss) from Baseline (Day 1) through Week 144
Time Frame: from Baseline (Day 1) through Week 144
Percentage
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (8)
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