In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
105
IVB group that receive 4 monthly IVB injections and then rescue IVB
PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB
Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser
Ophthalmic Research Center
Tehran, Iran
RECRUITINGExtent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG
Number of neovascular tissue counted by investigator according to FAG
Time frame: 12 months
Best corrected visual acuity based on Snellen chart
Time frame: 12 months
Central retinal thickness according to macular OCT
Time frame: 12 months
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