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Corticosteroid
Dexamethasone intravitreal implant for Retinal Vein Occlusion
N/A
Waitlist Available
Research Sponsored by Brian Burke, MPH
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 6 months
Awards & highlights
Study Summary
This study seeks to compare dexamethasone implant with rescue intravitreal ranibizumab to monthly intravitreal ranibizumab for the treatment of macular edema secondary to branch or central retinal vein occlusion. This is based on the null hypothesis that dexamethasone implant with rescue ranibizumab has inferior best corrected visual acuity at six months compared to monthly ranibizumab alone.
Eligible Conditions
- Retinal Vein Occlusion
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best Corrected Visual Acuity
Secondary outcome measures
Foveal Thickness
Side effects data
From 2018 Phase 3 trial • 192 Patients • NCT023740602%
Ocular hypertension
2%
colitis
2%
knee arthroplasty
2%
Investigation
2%
injection site injury
2%
bursitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Periocular Triamcinolone 40mg
Intravitreal Triamcinolone 4mg
Dexamethasoneintravitreal Implant
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dexamethasone intravitreal implantExperimental Treatment1 Intervention
Patients will receive a dexamethasone intravitreal implant injection at day 0.
During monthly visits 1,2,3, and 5, patients will receive a ranibizumab intravitreal injection if the macula SD-OCT during that visit shows mean central foveal thickness ≥ 250 μm or the best-corrected visual acuity is 20/40 or worse. The injection procedure is described in the next section.
During monthly visit 4, patients will receive a dexamethasone intravitreal implant injection if the macula SD-OCT during that visit shows mean central foveal thickness ≥ 250 μm or the best-corrected visual acuity is 20/40 or worse.
Group II: Monthly RanibizumabActive Control1 Intervention
• Patients will receive a ranibizumab intravitreal injection on day 0. During each other visit, patients will receive a ranibizumab intravitreal injection. The protocol will use the term "monthly" to represent a 30 day interval between treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphenhydramine
FDA approved
Find a Location
Who is running the clinical trial?
Brian Burke, MPHLead Sponsor
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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