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OTX-TKI for Macular Degeneration

NW
CP
Overseen ByClinical Project Manager
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ocular Therapeutix, Inc.
Disqualifiers: Intraocular infection, Intraocular inflammation, Retinal detachment, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

DD

Dilsher Dhoot, MD

Principal Investigator

California Retina Consultants (CRC)-Santa Barbara

Are You a Good Fit for This Trial?

Inclusion Criteria

Are able and willing to comply with all study requirements and visits
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 provided written informed consent
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Exclusion Criteria

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
I am not pregnant, breastfeeding, or planning pregnancy, and I will use two effective contraceptives.
I have had inflammation inside my study eye before.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants continue receiving the OTX-TKI (Axitinib Implant) to evaluate long-term safety

144 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • OTX-TKI

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: OTX-TKIExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ocular Therapeutix, Inc.

Lead Sponsor

Trials
55
Recruited
6,400+

Duke Reading Center

Collaborator

Fortrea

Industry Sponsor

Trials
22
Recruited
5,800+

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