Clinical Trial: Ozurdex for Retinal Vein Occlusion Study (ORVO Study)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ozurdex for Retinal Vein Occlusion Study (ORVO Study)

Brief Summary: To measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema after an injection of Ozurdex.

Detailed Summary: To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 4 weeks after intraocular injection of OZURDEX.
Sponsor: Johns Hopkins University

Current Primary Outcome: Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex [ Time Frame: 4 months ]

Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.


Original Primary Outcome: The primary outcome measure is a composite outcome that includes change from baseline in aqueous levels of VEGF, SDF-1, and angiopoietin-2 at 1, 2, 3, and 4 months after injection of OZURDEX. [ Time Frame: 4 months ]

Current Secondary Outcome:

Original Secondary Outcome: Measure Efficacy and safety parameters; these are composite outcomes [ Time Frame: 4 months ]

Determine the percentage of patients with CRVO or BRVO with ≥15, ≥10, or ≥5 letters at 1, 2, 3, and 4 weeks after injection.

Determine the percentage of patients with reduction in excess foveal thickness by 50% or 90% at Weeks 24, and 48.

Assess safety parameters including changes in intraocular pressure from baseline.



Information By: Johns Hopkins University

Dates:
Date Received: February 8, 2013
Date Started: February 2013
Date Completion:
Last Updated: April 2, 2015
Last Verified: April 2015