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

Combination Therapy for PDR

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 Overview

• Status: Unknown
• Conditions: Proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: receive 4 monthly IVB injections and then rescue IVB; Drug: PRP group; Drug: IVB injections and a modified laser

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Ophthalmic Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intravitreal bevacizumab injections and then rescue	Drug: receive 4 monthly IVB injections and then rescue IVB; IVB group that receive 4 monthly IVB injections and then rescue IVB
Active Comparator: PRP group	Drug: PRP group; PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB
Active Comparator: IVB injections and a modified laser	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent 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	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Best corrected visual acuity based on Snellen chart	12 months
Central retinal thickness according to macular OCT	12 months

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Publications and helpful links

General Publications

• Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 28, 2019
• First Submitted That Met QC Criteria: March 13, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 13, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 97378

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No