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Gene Therapy

Suprachoroidal CLS-AX for Age-Related Macular Degeneration (ODYSSEY Trial)

Phase 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 baseline, weeks 4, 12, 16, 20, 24, 28, 32 and 36
Awards & highlights
No Placebo-Only Group

Summary

This trial assesses safety and effectiveness of an injection to treat age-related macular degeneration in people previously treated with a standard of care.

Who is the study for?
This trial is for people with a specific eye condition called neovascular age-related macular degeneration (nAMD) who have had 2-4 previous anti-VEGF injections. Their vision in the study eye should be within a certain range, and they must have responded to prior treatments. They can't join if they have other major eye issues or very thick retinal or subretinal layers.
What is being tested?
The trial tests CLS-AX given behind the retina against Aflibercept, an existing treatment injected into the eyeball. It's to see which is better at treating nAMD over 36 weeks. Participants are randomly assigned to one of these two groups and won't know which treatment they're getting.
What are the potential side effects?
Possible side effects include discomfort at the injection site, inflammation inside the eye, changes in vision, bleeding inside the eye, and increased pressure within the eyeball. The exact side effects will depend on individual reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 12, 16, 20, 24, 28, 32 and 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 12, 16, 20, 24, 28, 32 and 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time
Secondary study objectives
Evaluation of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs)
Evaluation of the Number of Study Drug Injections and Supplemental Therapy Injections in the Study Eye Over Time
Evaluations of Outcomes Related to Fluid Detected on Optical Coherence Tomography in the Study Eye Over Time
+1 more

Side effects data

From 2022 Phase 1 & 2 trial • 27 Patients • NCT04626128
13%
Macular degeneration
13%
Blood lactate dehydrogenase increased
13%
Insomnia
13%
Ventricular extrasystoles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 4 (High Dose)
Cohort 1 (Low Dose)
Cohort 2 (Low-mid Dose)
Cohort 3 (High-mid Dose)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1.0 mg CLS-AXExperimental Treatment1 Intervention
Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX
Group II: AfliberceptActive Control1 Intervention
Intravitreal injection of aflibercept (2 mg in 0.05 mL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CLS-AX
2021
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Clearside Biomedical, Inc.Lead Sponsor
13 Previous Clinical Trials
1,248 Total Patients Enrolled
2 Trials studying Macular Degeneration
42 Patients Enrolled for Macular Degeneration
Susan Coultas, PhDStudy DirectorClearside Biomedical, Inc.
2 Previous Clinical Trials
42 Total Patients Enrolled
2 Trials studying Macular Degeneration
42 Patients Enrolled for Macular Degeneration

Media Library

CLS-AX (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05891548 — Phase 2
Macular Degeneration Research Study Groups: 1.0 mg CLS-AX, Aflibercept
Macular Degeneration Clinical Trial 2023: CLS-AX Highlights & Side Effects. Trial Name: NCT05891548 — Phase 2
CLS-AX (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05891548 — Phase 2
~25 spots leftby Nov 2025
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