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Anti-metabolites
ADX-2191 (intravitreal methotrexate 0.8%) for Proliferative Vitreoretinopathy
Phase 3
Waitlist Available
Research Sponsored by Aldeyra Therapeutics, 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 up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests a treatment called ADX-2191 to prevent a serious eye condition that can lead to vision loss. It targets patients who are at risk of developing this condition by stopping the growth of scar tissue inside the eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ADX-2191 (intravitreal methotrexate 0.8%)Experimental Treatment1 Intervention
ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.
Group II: Standard surgical care procedureActive Control1 Intervention
Standard procedure performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADX-2191 (intravitreal methotrexate 0.8%)
2019
Completed Phase 3
~110
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Who is running the clinical trial?
Aldeyra Therapeutics, Inc.Lead Sponsor
32 Previous Clinical Trials
4,564 Total Patients Enrolled
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