Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00423059

Enrollment

Registered

2007-01-17

Start date

2006-12-31

Completion date

2007-03-31

Last updated

2007-03-13

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

Conditions

Diabetic Retinopathy

Keywords

intravitreal bevacizumab, proliferative diabetic retinopathy, VEGF, PEDF

Brief summary

Recently, intravitreal bevacizumab (Avastin) injection has gained popularity as a potential treatment of intraocular neovascularization (CNV) associated with age related macular degeneration and diabetic retinopathy. The efficacy of the drug is thought to be related with its pharmacologic blockade of VEGF. The purpose of this study is to determine the effect of the intravitreal bevacizumab on the fibrovascular membrane associated with proliferative diabetic retinopathy by objective histologic evaluation. The patients scheduled for vitrectomy for tractional fibrovascular membrane due to proliferative diabetic retinopathy will be randomized into two treatment groups. The one will receive conventional vitrectomy and the other group will receive intravitreal bevacizumab injection one week before the scheduled vitrectomy. The fibrovascular membrane will be excised during surgery and fixated for histologic examinations. The expression of VEGF and PEDF, a potent inhibitor of angiogenesis, will be evaluated in the fibrovascular membrane by immunohistochemistry. The results will be compared between two treatment groups.

Interventions

DRUGbevacizumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Tractional retinal detachment recently involving the macula with fibrovascular membrane due to proliferative diabetic retinopathy * Severe fibrovascular proliferation progressing after appropriate panretinal photocoagulation

Exclusion criteria

* Uncontrolled systemic hypertension * Recent history of myocardiac infarction within 6 months * Recent history of cerebrovascular accident within 6 months

Design outcomes

Primary

Measure	Time frame
expression level of VEFG	—
PEDG	—
Factor VIII	—

Secondary

Measure	Time frame
complication rate	—

Countries

South Korea

Outcome results

None listed

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