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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

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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 • NCT02374060
3%
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

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
~2 spots leftby Oct 2025
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