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Keep this study
Lead
Clearside Biomedical, Inc.
Multi-center, open-label, dose-escalation, phase 1/2a, safety and tolerability study to evaluate four dose groups of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in up to a maximum of 25 subjects with neovascular age-related macular degeneration
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of neovascular age-related macular degeneration in the study eye.
Active subfoveal choroidal neovascularization (CNV) secondary to AMD
Two or more prior anti-VEGF intravitreal injections
EDTRS BCVA score ≤ 75 and ≥ 20 letters
You may not be if
Any active ocular disease, ocular disorders or conditions, prior ocular surgery or infection in the study eye other than nAMD
Other than IVT anti-VEGF treatments, no topical ocular or intraocular or periocular corticosteroid, or other treatments for CNV
IOP ≥ 25mmHg or cup-to-disc ratio \>0.8
Uncontrolled systemic disease (high risk or evidence of arterial and venous thromboembolism, CVA or stroke, unstable cardiovascular disease, uncontrolled hyperthyroidism, poor glycemic control, gastrointestinal bleed and/or high risk of GI perforation or fistula formation) or any other condition or therapy that would make the participant unsuitable for the study
Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the Screening visit
Clareo Health | Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD
