Clinical Trial: Ranibizumab in Patients With Branch Retinal Vein Occlusion

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

Official Title: Response of Retinal Vessels to Anti Vascular Endothelial Growth Factor (VEGF) Treatment in Patients With Branch Retinal Vein Occlusion (BRVO)

Brief Summary: In a recent study we could show that the early retinal venous vasoconstriction after grid photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual outcome after three months. This could be of clinical importance, because the degree of vasoconstriction might be an early marker of treatment success, compatible with the idea that hypoxia is the major trigger of VEGF in BRVO. The present study evaluates the response of retinal vessel diameters to anti VEGF treatment with lucentis in patients with BRVO. This is done in an effort to gain insight into the retinal hemodynamic consequences of anti VEGF treatment in BRVO. The hypothesis that anti VEGF treatment is associated with a vasoconstrictor response in retinal vessel in patients with BRVO is tested.

Detailed Summary:

To investigate the response of retinal vessel diameters to lucentis treatment in patients with BRVO and to correlate these changes with changes in functional outcome after 3 months.

Pilot study in patients scheduled for intravitreal anti-VEGF (Lucentis™) treatment with BRVO

30 patients with BRVO scheduled for intravitreal anti-VEGF treatment Intravitreous administration of Ranibizumab (Lucentis ™)

Main outcome measure: Retinal vessel diameters

Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with Microperimetry, objective functional response assessed with mfERG, anatomic changes in the macula region as assessed with StratusOCT and prototype of a Cirrus-OCT(which is available at the Department of Ophthalmology, Medical University of Vienna), angiographical outcomes.

Sponsor: Medical University of Vienna

Current Primary Outcome: Main outcome measure: Retinal vessel diameters [ Time Frame: weeks 1, 4 and 16 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity, objective functional response, anatomic changes in the macula region, angiographical outcomes. [ Time Frame: weeks 1,4 and16 ]

Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: December 7, 2009
Date Started: December 2007
Date Completion:
Last Updated: December 7, 2009
Last Verified: November 2007