Neovascular Age-Related Macular Degeneration (nAMD)Phase 3NCT07516132
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
A Phase 3 study testing OTX-TKI in people with Neovascular Age-Related Macular Degeneration (nAMD), run by Ocular Therapeutix, Inc. at 8 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD)
- What is being tested?
- OTX-TKI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Apr 2026to 1 Aug 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Austin Retina Associates
Austin, Texas, 78705
Robert William Wong, MD, 512-451-0103
Robert William Wong, MD
- Recruiting
California Retina Consultants (CRC)
Bakersfield, California, 93309
Luis Lopez, 661-524-0162, luis.lopez@californiaretina.com
Dilsher Dhoot, MD
- Recruiting
Retina Group of Florida - Fort Lauderdale
Fort Lauderdale, Florida, 33308
Eduardo Uchiyama, MD, 954-776-6800, euchiyama@rgfla.com
Eduardo Uchiyama, MD
- Recruiting
Cumberland Valley Retina Associates
Hagerstown, Maryland, 21740
Brittany Carson, 301-665-1712, BrittanyC@retinacare.net
Allen Hu, MD
- Recruiting
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740
Adam Gerstenblith, MD, 240-313-9500, adamgerstenblith@gmail.com
Adam Gerstenblith, MD
- Recruiting
California Retina Consultants (CRC)
Santa Barbara, California, 93103
Dilsher Dhoot, MD, 781-357-4000, ddhoot@yahoo.com
- Recruiting
Retina Group of New England
Waterford, Connecticut, 06385
Ashley Parent, 860-444-1292, aparent@retinagroupofnewengland.com
Nauman A Chaudhry, MD
- Recruiting
Palmetto Retina Center
West Columbia, South Carolina, 29619
Nitin Nigam, MD, 803-867-7059, nnigam@palmettoretina.com
Nitin Nigam, MD
About this study
Official title: A Phase 3b, Multicenter, Open-Label, Extension 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
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 tested
- OTX-TKI
- Keywords
- Neovascular Age-Related Macular Degeneration, Tyrosine Kinase Inhibitor, OTX-TKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-TKIDrug
Intravitreal Injection of OTX-TKI
| Study group | Role | What they receive |
|---|---|---|
| OTX-TKI | Experimental | Not described Receives: Drug: OTX-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144
Number of events
Measured: 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
Measured: from Baseline (Day 1) through Week 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start27 Apr 2026
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea, Duke Reading Center
- Responsible party
- Sponsor
- Investigators
- Dilsher Dhoot, MD, Principal investigator, California Retina Consultants (CRC)-Bakersfield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516132
- Sponsor's protocol ID
- OTX-TKI-2025-AMD-301
- Other IDs
- SOL-X
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicenter, Open-Label, Extension 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
- ClinicalTrials.gov ID
- NCT07516132
- Acronym / sponsor ID
- OTX-TKI-2025-AMD-301
- Keywords
- Neovascular Age-Related Macular Degeneration, Tyrosine Kinase Inhibitor, OTX-TKI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fortrea, Duke Reading Center
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTX-TKI | Experimental | Drug: OTX-TKI |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTX-TKIIntravitreal Injection of OTX-TKI | Drug | OTX-TKI |
Primary outcome
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
Number of events
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
Percentage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dilsher Dhoot, MD principal investigator
California Retina Consultants (CRC)-Bakersfield
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OTX-TKI in people with Neovascular Age-Related Macular Degeneration (nAMD), run by Ocular Therapeutix, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (781-357-4000, clinicalaffairs@ocutx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.