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

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:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

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
1: Experimental 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
2: Sham Comparator 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

Study ID Numbers:	8657
Study First Received:	September 4, 2007
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00524875 History of Changes
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:

Antineoplastic Agents
Eye Diseases
Growth Substances
Physiological Effects of Drugs
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors

Pharmacologic Actions
Diabetic Angiopathies
Diabetic Retinopathy
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on November 27, 2009