NCT07516132RecruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 850 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 27 Apr 2026
- Primary completion date
- 1 Aug 2030
- Lead sponsor
- Ocular Therapeutix, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT07516132
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 850
- From 27 Apr 2026 to the primary completion date, 1 Aug 2030
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1
Other illness
- History of intraocular inflammation in the study eye
- 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
Other
- 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
- 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.
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Retina Associates Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| California Retina Consultants (CRC) Coordinator of this site? Confirm its status | Bakersfield | United States | Recruiting |
| Retina Group of Florida - Fort Lauderdale Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Recruiting |
| Mid Atlantic Retina Specialists Coordinator of this site? Confirm its status | Hagerstown | United States | Recruiting |
| Cumberland Valley Retina Associates Coordinator of this site? Confirm its status | Hagerstown | United States | Recruiting |
| California Retina Consultants CRC Coordinator of this site? Confirm its status | Santa Barbara | United States | Recruiting |
| Retina Group of New England Coordinator of this site? Confirm its status | Waterford | United States | Recruiting |
| Palmetto Retina Center Coordinator of this site? Confirm its status | West Columbia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.