NCT07516132 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
| NCT ID | NCT07516132 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ocular Therapeutix, Inc. |
| Condition | Neovascular Age-Related Macular Degeneration (nAMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 850 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2030-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 850 participants in total. It began in 2026-04-27 with a primary completion date of 2030-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Dilsher Dhoot, MD
PRINCIPAL INVESTIGATOR
California Retina Consultants (CRC)-Bakersfield
Frequently Asked Questions
Who can join the NCT07516132 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Neovascular Age-Related Macular Degeneration (nAMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07516132 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 850 participants.
Is NCT07516132 currently recruiting?
Yes, NCT07516132 is actively recruiting participants. Contact the research team at clinicalaffairs@ocutx.com for enrollment information.
Where is the NCT07516132 trial being conducted?
This trial is being conducted at Bakersfield, United States, Santa Barbara, United States, Waterford, United States, Fort Lauderdale, United States and 4 additional locations.
Who is sponsoring the NCT07516132 clinical trial?
NCT07516132 is sponsored by Ocular Therapeutix, Inc.. The principal investigator is Dilsher Dhoot, MD at California Retina Consultants (CRC)-Bakersfield. The trial plans to enroll 850 participants.