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

NCT ID: NCT00524875

Last Updated: 2007-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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1

Intravitreal bevacizumab injection 1-2 weeks before surgery

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

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

2

Sham injection (needleless syringe pressed against conjunctiva)

Group Type SHAM_COMPARATOR

Bevacizumab

Intervention Type DRUG

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

Interventions

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Bevacizumab

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Hamid Ahmadieh, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

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Hamid Ahmadieh, MD

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Hamid Ahmadieh, MD

Role: CONTACT

[email protected]
+98 21 22585952

Facility Contacts

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Hamid Ahmadieh, MD

Role: primary

[email protected]
+98 21 22585952

Other Identifiers

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8657

Identifier Type: -

Identifier Source: org_study_id