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

Completed · Phase 1/Phase 2

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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)

Key facts

Study ID

NCT04626128

Run by

Clearside Biomedical, Inc.

People needed

27

Starts

2020-12-15

Expected to finish

2022-10-13

Last updated by the study team

2023-09-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Retinal Consultants of Arizona — Phoenix, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• Northern California Retina Vitreous Associates Medical Group, LLC — Mountain View, California, United States
• Retinal Consultants Medical Group — Sacramento, California, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Austin Retina Associates — Austin, Texas, United States
• Retina Consultants of Texas — Bellaire, Texas, United States
• Retina Consultants of Texas — San Antonio, Texas, United States
• Retina Consultants of Texas — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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