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Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

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Yonsei University

Status

Completed

Conditions

Diabetic Retinopathy

Treatments

Drug: bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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