Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD

OASIS: Open-label, Dose-escalation, Phase 1/2a Study of the Safety and Tolerability of Suprachoroidally Administered CLS-AX Following Intravitreal Anti-VEGF Therapy in Subjects With Neovascular Age-related Macular Degeneration

To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD)

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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