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

Phase 2

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Drug: receive 4 monthly IVB injections and then rescue IVB; Drug: PRP group; Drug: IVB injections and a modified laser

• Registration Number: NCT04800679
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-28
• Study Start: 2020-03-01
• Primary Completion: 2020-07-01
• Status Verified: 2020-12
• Study First Submitted QC: 2021-03-13
• Last Update Submitted: 2021-03-13
• Study First Posted: 2021-03-16
• Last Update Posted: 2021-03-16
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Presence of PDR with the indication of full PRP according the intend of investigator
• Best corrected visual acuity of 20/320 or better
• Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT

Exclusion Criteria

• History of prior PRP with more than 100 burns outside the posterior pole
• Tractional retinal detachment involving the macula
• Evidence of neoplasia of angle on examination
• Macular edema due to a cause other than DME
• Any ocular condition which may change visual acuity during the study
• Substantial cataract which has declined the vision by 3 lines or more
• History of intravitreal injection of anti-VEGF agent in past 2 months
• History of any use of corticosteroid during past 4 months
• History of major intra-ocular surgery except cataract surgery
• History of YAG laser capsulotomy during past 2 months
• Aphakia and uncontrolled glaucoma according to investigator judgment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravitreal bevacizumab injections and then rescue	receive 4 monthly IVB injections and then rescue IVB	-
PRP group	PRP group	-
IVB injections and a modified laser	IVB injections and a modified laser	-

Primary Outcome Measures

Name	Time	Method
Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG	12 months	Number of neovascular tissue counted by investigator according to FAG

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity based on Snellen chart	12 months
Central retinal thickness according to macular OCT	12 months

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of