Recruiting
Phase 3

OTX-TKI

Sponsor:

Ocular Therapeutix, Inc.

Code:

NCT07516132

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

OTX-TKI

Study Details

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

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Study ID

NCT07516132

Start date

Apr 27, 2026

Status verified date

Jun, 2026

Completion date

Aug 1, 2030

Anticipated

Primary completion date

Aug 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

850 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OTX-TKI

Interventions

OTX-TKI

Intravitreal Injection of OTX-TKI

Primary outcome measure

  • Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144 [ Time Frame: from Baseline (Day 1) through Week 144 ]
  • Proportion of participants with severe vision loss (defined as ≥ 30 Early Treatment Diabetic Retinopathy Study [ETDRS] letters loss) from Baseline (Day 1) through Week 144 [ Time Frame: from Baseline (Day 1) through Week 144 ]

Central Contacts and Locations

Central contacts

Clinical Project Manager

781-357-4000clinicalaffairs@ocutx.com

Nichole Wilkes

770-375-1020nwilkes@ocutx.com

Locations

California Retina Consultants (CRC)

Recruiting

Bakersfield, California, United States, 93309

Contacts

Luis Lopez

661-524-0162luis.lopez@californiaretina.com

Principal Investigator:

Dilsher Dhoot, MD

California Retina Consultants (CRC)

Recruiting

Santa Barbara, California, United States, 93103

Contacts

Dilsher Dhoot, MD

781-357-4000ddhoot@yahoo.com

Retina Group of New England

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Ashley Parent

860-444-1292aparent@retinagroupofnewengland.com

Principal Investigator:

Nauman A Chaudhry, MD

Retina Group of Florida - Fort Lauderdale

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Eduardo Uchiyama, MD

954-776-6800euchiyama@rgfla.com

Principal Investigator:

Eduardo Uchiyama, MD

Cumberland Valley Retina Associates

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Brittany Carson

301-665-1712BrittanyC@retinacare.net

Principal Investigator:

Allen Hu, MD

Mid Atlantic Retina Specialists

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Adam Gerstenblith, MD

240-313-9500adamgerstenblith@gmail.com

Principal Investigator:

Adam Gerstenblith, MD

Palmetto Retina Center

Recruiting

West Columbia, South Carolina, United States, 29619

Contacts

Nitin Nigam, MD

803-867-7059nnigam@palmettoretina.com

Principal Investigator:

Nitin Nigam, MD

Austin Retina Associates

Recruiting

Austin, Texas, United States, 78705

Contacts

Robert William Wong, MD

512-451-0103

Principal Investigator:

Robert William Wong, MD

More Information

Sponsor

Ocular Therapeutix, Inc.

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Neovascular Age-Related Macular Degeneration
  • Tyrosine Kinase Inhibitor
  • OTX-TKI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ocular Therapeutix, Inc. on 2026-07-01.