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Active (not recruiting) Phase 3 NCT06495918

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration

Phase 3 – large-scale trial before approval
Conditions: Neovascular Age-related Macular Degeneration

Sponsor: Ocular Therapeutix, Inc.

trial.available_in: БГ
Overview
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration
Who can participate
Inclusion Criteria: * Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening * Have provided written consent Exclusion Criteria: * Monocular subject or Best Corrected Visual Acuity (BCVA) score of \<20 ETDRS letters or 20/400 in fellow eye at Screening * Have evidence of a scar, fibrosis, or atrophy of \>50% of the total lesion in the study eye.
Locations 4
Argentina (1)
Organización Médica de Investigación (OMI)
Buenos Aires
Australia (1)
Albury Eye Clinic
Albury , New South Wales
Puerto Rico (1)
Emanuelli Research and Development Center, LLC
Arecibo
United States (1)
Associated Retina Consultant
Gilbert , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
50 Years
Healthy volunteers
No
Start date
27.11.2024
Completion date
08.01.2027
Registry ID
NCT06495918
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.