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

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clearside Biomedical, Inc.
• Treatments: Aflibercept; Axitinib

Criteria

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