Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
NCT ID: NCT04989699
Last Updated: 2024-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2021-07-28
2023-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OTX-TKI
OTX-TKI/Sham
OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
Aflibercept
Aflibercept/Sham
Aflibercept administered every 8 weeks
Interventions
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OTX-TKI/Sham
OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
Aflibercept/Sham
Aflibercept administered every 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
* Must have received at least 3 anti-VEGF injections in the past year.
* Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit.
* BCVA ETDRS score between 24 and 83 letters (\~20/25 to \~20/320 Snellen equivalent)
Exclusion Criteria
* Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments
* Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse
50 Years
ALL
No
Sponsors
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Ocular Therapeutix, Inc.
INDUSTRY
Responsible Party
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Locations
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Ocular Therapeutix
Bakersfield, California, United States
Ocular Therapeutix
Oxnard, California, United States
Ocular Therapeutix
Altamonte Springs, Florida, United States
Ocular Therapeutix
St. Petersburg, Florida, United States
Ocular Therapeutix
Reno, Nevada, United States
Ocular Therapeutix
The Woodlands, Texas, United States
Countries
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Other Identifiers
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OTX-TKI-2020-101
Identifier Type: -
Identifier Source: org_study_id
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