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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

RecruitingPhase 3Ages 50 Years - anyAllOcular Therapeutix, Inc.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • OTX-TKI
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Where

8 sites
California Retina Consultants (CRC)
Bakersfield, United States
California Retina Consultants (CRC)
Santa Barbara, United States
Retina Group of New England
Waterford, United States
Retina Group of Florida - Fort Lauderdale
Fort Lauderdale, United States
Cumberland Valley Retina Associates
Hagerstown, United States
Mid Atlantic Retina Specialists
Hagerstown, United States
Palmetto Retina Center
West Columbia, United States
Austin Retina Associates
Austin, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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