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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2007 by Shaheed Beheshti Medical University. Recruitment status was Recruiting

First Received on September 4, 2007. No Changes Posted

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00524875

Purpose

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.

Condition	Intervention
Diabetic Retinopathy	Drug: Bevacizumab

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

early post-vitrectomy vitreous hemorrhage

Secondary Outcome Measures:

Visual improvement

Estimated Enrollment:	80
Study Start Date:	January 2007
Estimated Study Completion Date:	September 2007

Arms	Assigned Interventions
Experimental: 1 Intravitreal bevacizumab injection 1-2 weeks before surgery	Drug: Bevacizumab One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy
Sham Comparator: 2 Sham injection (needleless syringe pressed against conjunctiva)	Drug: Bevacizumab One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524875

Contacts

Contact: Hamid Ahmadieh, MD

+98 21 22585952

hahmadieh@hotmail.com

Locations

Iran, Islamic Republic of
Hamid Ahmadieh, MD	Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Hamid Ahmadieh, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00524875 History of Changes
Other Study ID Numbers:	8657
Study First Received:	September 4, 2007
Last Updated:	September 4, 2007
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

Proliferative diabetic retinopathy
Bevacizumab
Early post-vitrectomy vitreous hemorrhage

Additional relevant MeSH terms:

Diabetic Retinopathy
Hemorrhage
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012