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Monoclonal Antibodies
Aflibercept 2.0mg for Central Retinal Vein Occlusion
Phase 4
Waitlist Available
Led By Franco M Recchia, MD
Research Sponsored by Tennessee Retina
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
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
The purpose of this study is determine the number of patients with complete resolution of macular edema secondary to central retinal vein occlusion following 6 monthly injections of Aflibercept.
Eligible Conditions
- Central Retinal Vein Occlusion
- Retinal Vein Occlusion
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
Side effects data
From 2015 Phase 4 trial • 26 Patients • NCT016171484%
Cataract progression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Group
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Aflibercept 2.0mgExperimental Treatment1 Intervention
Single arm - Intravitreal Aflibercept 2.0mg, 0.05 milliliters, monthly for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept
FDA approved
Find a Location
Who is running the clinical trial?
Tennessee RetinaLead Sponsor
2 Previous Clinical Trials
52 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
386,493 Total Patients Enrolled
Franco M Recchia, MDPrincipal InvestigatorTennessee Retina, PC
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