Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

NCT ID: NCT01025934

Last Updated: 2009-12-04

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

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.

Detailed Description

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Conditions

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Proliferative Diabetic Retinopathy

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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7 days

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

20 days

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

sham

Group Type SHAM_COMPARATOR

sham

Intervention Type OTHER

Interventions

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Bevacizumab

Intervention Type DRUG

sham

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* vitreous haemorrhage
* tractional retinal detachment
* active proliferative diabetic retinopathy.

Exclusion Criteria

* neovascular glaucoma
* cataract
* combined traction and rhegmatogenous RD
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Napoli CTO Hospital

UNKNOWN

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

References

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di Lauro R, De Ruggiero P, di Lauro R, di Lauro MT, Romano MR. Intravitreal bevacizumab for surgical treatment of severe proliferative diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2010 Jun;248(6):785-91. doi: 10.1007/s00417-010-1303-3. Epub 2010 Feb 5.

Reference Type DERIVED
PMID: 20135139 (View on PubMed)

Other Identifiers

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IVBDRNA

Identifier Type: -

Identifier Source: org_study_id