drugset / Trial / NCT04800679

Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR

NCT04800679 ↗

Phase 2 Unknown 105 enrolled Shahid Beheshti University of Medical Sciences
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2020-03-01
Primary completion
2020-07-01
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody — Intravitreal