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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
intravitreal injections
Targeted Pan Retinal Photocoagulation based on wide field angiography
Retina Consultants of Houston/The Medical Center
Houston, Texas, United States
Retina Consultants of Houston
Katy, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Total Number of Intravitreal Injections Over a 12 Month Period
Assess the number of intravitreal injections over 12 months.
Time frame: 12 months
Visual Acuity
Evaluate the mean change from baseline in ETDRS best-corrected visual acuity at 12 months. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning.
Time frame: 12 month period
Retinal Ischemia
Quantify change in area of perfused and ischemic retina.
Time frame: 12 month period
Foveal Avascular Zone
Assess change in foveal avascular zone area and largest diameter, measured during the early phase of the angiogram
Time frame: 12 months
Adverse Events
Incidence and severity of adverse events (ocular and non-ocular).
Time frame: 12 months
Neovascularization of the Iris, Optic Nerve and Elsewhere
Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.
Time frame: 12 months
Central Foveal Outcome
Mean change in Central Foveal Volume on High Resolution OCT.
Time frame: 12 months
Aqueous VEGF Levels
VEGF, other cytokines and ranibizumab levels in aqueous and serum samples at randomization and at the exit or early termination visit.
Time frame: 12 Months
Visual Field
Goldman Visual Field changes at 6 and 12 months from baseline. Goldmann perimetry is a method used to map a patient's field of vision (central and peripheral). Changes will be assessed by manual digital quantification of GVF plots.
Time frame: 6 and 12 Months
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