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Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients

Primary Purpose

Diabetic Retinopathy

Status

Unknown status

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Bevacizumab

About this trial

This is an interventional prevention trial for Diabetic Retinopathy focused on measuring Proliferative diabetic retinopathy, Bevacizumab, Early post-vitrectomy vitreous hemorrhage

Eligibility Criteria

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

Inclusion Criteria:

All eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive PDR

Exclusion Criteria:

One eye patient
Best corrected visual acuity better than 20/50
Pregnancy
Use of internal tamponade such as silicone oil during surgery
Concurrent ophthalmic surgery such as cataract extraction

Sites / Locations

Hamid Ahmadieh, MDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm Description

Intravitreal bevacizumab injection 1-2 weeks before surgery

Sham injection (needleless syringe pressed against conjunctiva)

Outcomes

Primary Outcome Measures

early post-vitrectomy vitreous hemorrhage

Secondary Outcome Measures

Visual improvement

Full Information

NCT ID

NCT00524875

First Posted

September 4, 2007

Last Updated

September 4, 2007

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00524875

Brief Title

Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients.

Detailed Description

Diabetes is the leading cause of blindness in the age range of 20-64 years. Pars plana vitrectomy may be indicated for the management of advanced proliferative diabetic retinopathy. Early post-vitrectomy hemorrhage in diabetic patients is relatively common; it occurs in 29% -75% of patients in the first month after surgery. This may cause delayed visual rehabilitation and detection of surgical complications such as retinal break or detachment. Preliminary reports such as case series reported by Spaide RF, et al showed beneficial effect of bevacizumab in proliferative diabetic retinopathy complicated by vitreous hemorrhage.

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, Bevacizumab, Early post-vitrectomy vitreous hemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intravitreal bevacizumab injection 1-2 weeks before surgery

Arm Title

Arm Type

Sham Comparator

Arm Description

Sham injection (needleless syringe pressed against conjunctiva)

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy

Primary Outcome Measure Information:

Title

early post-vitrectomy vitreous hemorrhage

Secondary Outcome Measure Information:

Title

Visual improvement

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive PDR Exclusion Criteria: One eye patient Best corrected visual acuity better than 20/50 Pregnancy Use of internal tamponade such as silicone oil during surgery Concurrent ophthalmic surgery such as cataract extraction

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hamid Ahmadieh, MD

Phone

+98 21 22585952

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

hahmadieh@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients

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