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NCT07516132PHASE3Recruiting

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.

Start Date

4/27/2026

Completion Date

8/1/2030

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

Age Range: 50 years to No maximum

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.

Interventions

DRUG

OTX-TKI

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Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Locations

California Retina Consultants (CRC)

Bakersfield, California 93309

United States

California Retina Consultants (CRC)

Santa Barbara, California 93103

United States

Retina Group of New England

Waterford, Connecticut 06385

United States

Retina Group of Florida - Fort Lauderdale

Fort Lauderdale, Florida 33308

United States

Cumberland Valley Retina Associates

Hagerstown, Maryland 21740

United States

Mid Atlantic Retina Specialists

Hagerstown, Maryland 21740

United States

Palmetto Retina Center

West Columbia, South Carolina 29619

United States

Austin Retina Associates

Austin, Texas 78705

United States