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Monoclonal Antibodies
Aflibercept 2.0mg for 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 month 6
Awards & highlights
Study 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
- Retinal Vein Occlusion
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete anatomic resolution of macular edema following central retinal vein occlusion (CRVO) as measured by Optical Coherence Tomography (OCT)
Secondary outcome measures
Extent of reduction in macular thickness
Extent of reduction in macular volume
Mean change in best-corrected visual acuity (BCVA)
+2 moreOther outcome measures
Effect on macular leakage using fluorescein angiogram (FA)
Effect on peripheral retinal non-perfusion
Side effects data
From 2015 Phase 4 trial • 26 Patients • NCT016171484%
Cataract progression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Group
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
622 Previous Clinical Trials
380,721 Total Patients Enrolled
11 Trials studying Retinal Vein Occlusion
4,537 Patients Enrolled for Retinal Vein Occlusion
Franco M Recchia, MDPrincipal InvestigatorTennessee Retina, PC
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