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

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
receive 4 monthly IVB injections and then rescue IVB
PRP group
IVB injections and a modified laser
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

intravitreal bevacizumab injections and then rescue

PRP group

IVB injections and a modified laser

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Best corrected visual acuity based on Snellen chart
Central retinal thickness according to macular OCT

Full Information

First Posted
December 28, 2019
Last Updated
March 13, 2021
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04800679
Brief Title
Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR
Official Title
Combination Therapy for PDR
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravitreal bevacizumab injections and then rescue
Arm Type
Active Comparator
Arm Title
PRP group
Arm Type
Active Comparator
Arm Title
IVB injections and a modified laser
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
receive 4 monthly IVB injections and then rescue IVB
Intervention Description
IVB group that receive 4 monthly IVB injections and then rescue IVB
Intervention Type
Drug
Intervention Name(s)
PRP group
Intervention Description
PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB
Intervention Type
Drug
Intervention Name(s)
IVB injections and a modified laser
Intervention Description
Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser
Primary Outcome Measure Information:
Title
Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG
Description
Number of neovascular tissue counted by investigator according to FAG
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Best corrected visual acuity based on Snellen chart
Time Frame
12 months
Title
Central retinal thickness according to macular OCT
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alireza Ramezani, MD
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali reza Ramezani, MD
Phone
009822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35594075
Citation
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.
Results Reference
derived

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

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