NCT04800679

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

Combination Therapy for PDR

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	receive 4 monthly IVB injections and then rescue IVB	IVB group that receive 4 monthly IVB injections and then rescue IVB
DRUG	PRP group	PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB
DRUG	IVB injections and a modified laser	Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-07-01
• Completion: 2021-12-01
• First posted: 2021-03-16
• Last updated: 2021-03-16

Locations

1 site across 1 country: Iran