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CLS-AX for Age-Related Macular Degeneration (OASIS Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Clearside Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8 and 12
Awards & highlights

OASIS Trial Summary

This trial is testing a new way to give a common treatment for macular degeneration, and will evaluate how well tolerated it is.

Eligible Conditions
  • Age-Related Macular Degeneration

OASIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Serious Adverse Events
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Maximum Plasma Concentration [Cmax] of Axitinib
Mean Change From Baseline (Visit 2) in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Mean Change From Baseline (Visit 2) in Central Subfield Thickness (CST) in the Study Eye
+3 more

OASIS Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4 (High Dose)Experimental Treatment2 Interventions
Subjects will receive a high-mid dose of 1.0 mg CLS-AX
Group II: Cohort 3 (High-mid Dose)Experimental Treatment2 Interventions
Subjects will receive a high-mid dose of 0.50 mg CLS-AX
Group III: Cohort 2 (Low-mid Dose)Experimental Treatment2 Interventions
Subjects will receive a low-mid dose of 0.10 mg CLS-AX
Group IV: Cohort 1 (Low Dose)Experimental Treatment2 Interventions
Subjects will receive a low dose of 0.03 mg CLS-AX
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CLS-AX
2021
Completed Phase 2
~50
Anti-VEGF
2013
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

Clearside Biomedical, Inc.Lead Sponsor
13 Previous Clinical Trials
1,281 Total Patients Enrolled
Susan Coultas, PhDStudy DirectorClearside Biomedical, Inc.
2 Previous Clinical Trials
75 Total Patients Enrolled
Thomas Ciulla, MD, MBAStudy DirectorClearside Biomedical, Inc.
1 Previous Clinical Trials
15 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD
2020. "Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04626128.
~6 spots leftby Apr 2025
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