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Intravitreal Bevacizumab for Management of Active Progressive Proliferative Diabetic Retinopathy (PDR)

Primary Purpose

Diabetic Retinopathy

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
bevacizumab
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 Diabetic Retinopathy focused on measuring Proliferative diabetic retinopathy(PDR), Pan retinal photocoagulation (PRP), Vitreous hemorrhage, Traction retinal detachment, Neovascularization on disc (NVD), Neovascularization elsewhere (NVE), Fibrous proliferation on disc (FPD), Fibrous proliferaiton elsewhere (FPE)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cases of active progressive PDR with history of scatter laser photocoagulation Exclusion Criteria: history of vitrectomy

Sites / Locations

  • Hamid Ahmadieh, MDRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

Outcomes

Primary Outcome Measures

Regression of diabetic retinopathy
visual acuity

Secondary Outcome Measures

neovascularization
fibrous proliferation
traction retinal detachment
vitreous hemorrhage
pan retinal photocoagulation

Full Information

First Posted
August 30, 2006
Last Updated
June 25, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00370721
Brief Title
Intravitreal Bevacizumab for Management of Active Progressive Proliferative Diabetic Retinopathy (PDR)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in cases with the signs of active progressive PDR

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Proliferative diabetic retinopathy(PDR), Pan retinal photocoagulation (PRP), Vitreous hemorrhage, Traction retinal detachment, Neovascularization on disc (NVD), Neovascularization elsewhere (NVE), Fibrous proliferation on disc (FPD), Fibrous proliferaiton elsewhere (FPE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Primary Outcome Measure Information:
Title
Regression of diabetic retinopathy
Title
visual acuity
Secondary Outcome Measure Information:
Title
neovascularization
Title
fibrous proliferation
Title
traction retinal detachment
Title
vitreous hemorrhage
Title
pan retinal photocoagulation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cases of active progressive PDR with history of scatter laser photocoagulation Exclusion Criteria: history of vitrectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamid Ahmadieh, MD
Phone
+98 21 22585952
Email
hahmadieh@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamid Ahmadieh, MD
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Phone
+98 21 22585952
Email
hahmadieh@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Intravitreal Bevacizumab for Management of Active Progressive Proliferative Diabetic Retinopathy (PDR)

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