Central Retinal, Hemi Retinal & Brach Retinal Vein Occlusions Clinical Trial
Official title:
A Phase IV Open Label Trial of the Safety, Tolerability and Efficacy of 0.5mg Ranibizumab Intravitreal Injections Combined With Wide Field Angiography Guided Panretinal Photocoagulation vs. 0.5mg Ranibizumab Intravitreal Injection Monotherapy in Subjects With Ischemic Central Retinal Vein Occlusion, Hemi Retinal Vein Occlusion, and Branch Retinal Vein Occlusion Who Incompletely Respond to at Least 2 Consecutive Intravitreal Injections in the Past 4 Months.
To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease the total number of intravitreal injections in a year for ischemic central retinal vein occlusion, hemi-retinal vein occlusions and branch retinal vein occlusions compared to standard of care
The WAVE trial is a phase IV, open label, 12-month trial of intravitreal ranibizumab 0.5 mg
in patients (n=30) with ischemic CRVO, HRVO and BRVO who have been previously treated with
ranibizumab or any other anti-VEGF intravitreal injection therapy, who are incomplete
responders to 2 or more consecutive intravitreal anti-VEGF injections in the past 4 months.
Randomization is 1:4, 1=control, ranibizumab only, 4=treatment arm. In total, 6 subjects
will be randomized to control and 24 randomized to treatment arm.
Cohort 1- 24 Subjects previously treated Patients will receive 6 doses of ranibizumab 0.5
mg, followed by PRN intravitreal injection of ranibizumab 0.5 mg based on pre-defined
retreatment criteria for up to 11 total injections.
Wide field angiography guided peripheral targeted-retinal photocoagulation (TRP), will be
divided into 2 sessions if needed, one at the 2 weeks post injection visit and another later
at M4/V7, if repeat wide field angiogram indicates areas not sufficiently treated in the
first TRP session
Cohort 2- 6 Subjects, previously treated patients will receive 6 doses of ranibizumab 0.5
mg, followed by PRN intravitreal injection of ranibizumab 0.5 mg based on pre-defined
retreatment criteria for up to 11 total injections.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment