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Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT04626128•Clearside Biomedical, Inc.

View on ClinicalTrials.gov

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)

Detailed 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

Eligibility

Age

50 - No limit years

Sex

ALL

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

Locations (11)

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

Key Dates

Start Date

December 15, 2020

Primary Completion Date

October 13, 2022

Completion Date

October 13, 2022

Last Updated

September 18, 2023

Enrollment

ACTUAL participants

Conditions

Neovascular Age-related Macular Degeneration

Interventions

CLS-AX

DRUG

Anti-VEGF

DRUG

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

NCT05562947

Neovascular Age-related Macular DegenerationnAMD

View study

RECRUITINGPHASE3

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

NCT05904028

Neovascular Age-related Macular Degeneration

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

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