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Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration

NCT05891548 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-25

No results posted yet for this study

Summary

Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. Only one eye will be chosen as the study eye.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

DRUG

CLS-AX

CLS-AX will be administered by suprachoroidal injection into the study eye on Day 1 and then every 12 to 24 weeks as determined by protocol-defined disease activity criteria.

DRUG

Aflibercept

Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W).

Sponsors & Collaborators

  • Clearside Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Coultas, PhD · Clearside Biomedical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-08-20
Completion
2024-08-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05891548 on ClinicalTrials.gov