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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
ODYSSEY Trial 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.Check my eligibility
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.See study design
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.
ODYSSEY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 4, 12, 16, 20, 24, 28, 32 and 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 12, 16, 20, 24, 28, 32 and 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time
Secondary outcome measures
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 moreSide effects data
From 2022 Phase 1 & 2 trial • 27 Patients • NCT0462612817%
Atrial fibrillation
17%
Conjunctival haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 (Low Dose)
Cohort 2 (Low-mid Dose)
Cohort 3 (High-mid Dose)
Cohort 4 (High Dose)
ODYSSEY 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
Susan Coultas, PhDStudy DirectorClearside Biomedical, Inc.
2 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye has had 2-4 anti-VEGF injections for nAMD in the last 6 months.My eye condition is due to nAMD without major damage under the center of my vision.I was diagnosed with wet age-related macular degeneration in the past 3 years.I have a history of eye conditions not related to AMD that affect my vision.More than half of the lesion in my eye involves bleeding, scarring, or tissue loss.My eye improved with previous anti-VEGF injections.My vision loss is not due to AMD but another condition.
Research Study Groups:
This trial has the following groups:- Group 1: 1.0 mg CLS-AX
- Group 2: Aflibercept
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current sample population for this clinical research?
"Affirmative. According to information available on clinicaltrials.gov, this trial is actively searching for participants and was first posted on May 31st 2023. The latest update dates from June 4th of the same year, with 60 patients needed across a single site."
Answered by AI
Has the Food and Drug Administration greenlit 1.0 mg CLS-AX for use?
"The safety of 1.0 mg CLS-AX was assessed as a 2 because Phase 2 trials have been conducted and there is some data demonstrating its security, though none proving efficacy."
Answered by AI
Are there any vacancies available for participants in this research endeavor?
"Affirmative. Clinicaltrials.gov displays that this medical experiment, which was first published on May 31st 2023, is actively seeking volunteers. Approximately 60 test subjects need to be recruited from 1 specified center."
Answered by AI
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