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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00524875

Enrollment

Registered

2007-09-05

Start date

2007-01-31

Completion date

2007-09-30

Last updated

2007-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Proliferative diabetic retinopathy, Bevacizumab, Early post-vitrectomy vitreous hemorrhage

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.

Interventions

DRUGBevacizumab

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
early post-vitrectomy vitreous hemorrhage	—

Secondary

Measure	Time frame
Visual improvement	—

Countries

Iran

Contacts

Primary ContactHamid Ahmadieh, MD

hahmadieh@hotmail.com+98 21 22585952

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026