Protocol S by DRCR.net has shown that receive Ranibizumab as anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy, however with some visual functional benefits and less complications with Ranibizumab arm. Applying Protocol S in real world scenario may add cost burden to the patient as patients need about 7 injections per year which will cost the patient about 7000 US dollars a year as minimum The primary objective of this protocol is to determine the visual acuity outcomes at 1 year in eyes with proliferative diabetic retinopathy (PDR) using Bevacizumab 1.25 mg instead of Ranbizumab to lower the cost burden
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Drug: 1.25-mg Bevacizumab Intravitreal injection of 1.25 mg Bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria. Other: Deferred panretinal photocoagulation PRP is deferred until failure/futility criteria for intravitreal injection are met.
Panretinal photocoagulation (full session completed within 42 days).
Marashi Eye Clinic
Aleppo, Syria
Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year
Time frame: 1 year
Amount of treatment cost
Time frame: 1 year
Percent of eyes with vitreous hemorrhage
Time frame: 1 year
Proportion of eyes with complete regression of neovascularization on fundus photograph
Time frame: 1 year
Proportion of eyes with progression to central subfield involved diabetic macular edema
Time frame: 1 year
Proportion of eyes Need for Vitrectomy
Time frame: 1 year
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