NCT07516132

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for phase_3

Timeline
49mo left

Started Apr 2026

Typical duration for phase_3

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Aug 2030

First Submitted

Initial submission to the registry

March 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 27, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

4.3 years

First QC Date

March 31, 2026

Last Update Submit

June 29, 2026

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Keywords

Neovascular Age-Related Macular DegenerationTyrosine Kinase InhibitorOTX-TKI

Outcome Measures

Primary Outcomes (2)

  • Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144

    Number of events

    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

    Percentage

    from Baseline (Day 1) through Week 144

Study Arms (1)

OTX-TKI

EXPERIMENTAL
Drug: OTX-TKI

Interventions

OTX-TKIDRUG

Intravitreal Injection of OTX-TKI

OTX-TKI

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

California Retina Consultants (CRC)

Bakersfield, California, 93309, United States

RECRUITING

California Retina Consultants (CRC)

Santa Barbara, California, 93103, United States

RECRUITING

Retina Group of New England

Waterford, Connecticut, 06385, United States

RECRUITING

Retina Group of Florida - Fort Lauderdale

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Cumberland Valley Retina Associates

Hagerstown, Maryland, 21740, United States

RECRUITING

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740, United States

RECRUITING

Palmetto Retina Center

West Columbia, South Carolina, 29619, United States

RECRUITING

Austin Retina Associates

Austin, Texas, 78705, United States

RECRUITING

Study Officials

  • Dilsher Dhoot, MD

    California Retina Consultants (CRC)-Bakersfield

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Project Manager

CONTACT

781-357-4000clinicalaffairs@ocutx.com

Nichole Wilkes

CONTACT

770-375-1020nwilkes@ocutx.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

July 1, 2026

Record last verified: 2026-06

Locations

US(8)