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
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