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. · with Fortrea, Duke Reading Center · NCT07516132
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 850
- US sites recruiting
- 8
- Study start
- April 27, 2026
- Record last updated
- July 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: OTX-TKI
Conditions: Neovascular Age-Related Macular Degeneration (nAMD)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
California Retina Consultants (CRC)
Bakersfield, CA 93309
Site contact: Luis Lopez · 661-524-0162 · luis.lopez@californiaretina.com
California Retina Consultants (CRC)
Santa Barbara, CA 93103
Site contact: Dilsher Dhoot, MD · 781-357-4000 · ddhoot@yahoo.com
Retina Group of New England
Waterford, CT 06385
Site contact: Ashley Parent · 860-444-1292 · aparent@retinagroupofnewengland.com
Retina Group of Florida - Fort Lauderdale
Fort Lauderdale, FL 33308
Site contact: Eduardo Uchiyama, MD · 954-776-6800 · euchiyama@rgfla.com
Cumberland Valley Retina Associates
Hagerstown, MD 21740
Site contact: Brittany Carson · 301-665-1712 · BrittanyC@retinacare.net
Mid Atlantic Retina Specialists
Hagerstown, MD 21740
Site contact: Adam Gerstenblith, MD · 240-313-9500 · adamgerstenblith@gmail.com
Palmetto Retina Center
West Columbia, SC 29619
Site contact: Nitin Nigam, MD · 803-867-7059 · nnigam@palmettoretina.com
Austin Retina Associates
Austin, TX 78705
Site contact: Robert William Wong, MD · 512-451-0103
Study contacts (from the official record)
- Clinical Project Manager · 781-357-4000 · clinicalaffairs@ocutx.com
- Nichole Wilkes · 770-375-1020 · nwilkes@ocutx.com