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Osurdex as Adjunct to Avastin in RVO Macular Edema
NCT01085734Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2010
- Primary completion
- Oct 2011
- Countries
- 1
- Sponsor
- Raj K. Maturi MD
- Modality
- Orthosteric Ligands
- Conditions
- macular edema
01
Overview
Phase 4, randomised, double-blind trial of dexamethasone intravitreal implant in macular edema (2 arms), sponsored by Raj K. Maturi MD. Primary endpoint: Change From Baseline Visual Acuity at 6 Months. Started Mar 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Avastin + Sham
Avastin at baseline, Sham Osurdex at Week 1, Avastin PRN.
Avastin + Osurdex
Avastin at baseline, Osurdex at Week 1, Avastin PRN.
03
Who it enrols
Patients 18 years or older with Branch or Central Retinal Vein Occlusion of less than one year duration, BCVA between 24 and 80 letters, and macular edema (OCT > 250 microns). Excludes patients with recent anti-VEGF or steroid treatment, recent PRP, active iris neovascularization, uncontrolled systemic disease, or history of steroid-induced IOP elevation.
04
Endpoints
Primary
Change From Baseline Visual Acuity at 6 Months
Secondary
Number of Injections Needed
Change in Macular Thickness and Macular Volume
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