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

Clearside Biomedical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: CLS-AX; Drug: Anti-VEGF

Study type: Interventional

Funder types: Industry

Identifiers

NCT04626128

CLS1002-101

Details and patient eligibility

About

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)

Full description

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

Enrollment: 27 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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27 participants in 4 patient groups

Cohort 1 (Low Dose)

Experimental group

Description:

Subjects will receive a low dose of 0.03 mg CLS-AX

Treatment:

Drug: Anti-VEGF

Drug: CLS-AX

Cohort 2 (Low-mid Dose)

Experimental group

Description:

Subjects will receive a low-mid dose of 0.10 mg CLS-AX

Treatment:

Drug: Anti-VEGF

Drug: CLS-AX

Cohort 3 (High-mid Dose)

Experimental group

Description:

Subjects will receive a high-mid dose of 0.50 mg CLS-AX

Treatment:

Drug: Anti-VEGF

Drug: CLS-AX

Cohort 4 (High Dose)

Experimental group

Description:

Subjects will receive a high-mid dose of 1.0 mg CLS-AX

Treatment:

Drug: Anti-VEGF

Drug: CLS-AX