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Corticosteroid
Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to 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
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
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
- Central Retinal Vein Occlusion
- 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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best Corrected Visual Acuity
Secondary study objectives
Foveal Thickness
Side effects data
From 2018 Phase 3 trial • 192 Patients • NCT023740603%
Intraocular pressure increased
2%
chronic obstructive pulmonary disease
2%
pulmonary hypertension
2%
mediastinoscopy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravitreal Triamcinolone 4mg
Periocular Triamcinolone 40mg
Dexamethasoneintravitreal Implant
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.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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