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Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT01025934
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : December 4, 2009
Sponsor:
Collaborator:
Napoli CTO Hospital
Information provided by:
University of Campania "Luigi Vanvitelli"

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: Bevacizumab Other: sham Phase 4

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 7 days Drug: Bevacizumab
Active Comparator: 20 days Drug: Bevacizumab
Sham Comparator: sham Other: sham


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • neovascular glaucoma
  • cataract
  • combined traction and rhegmatogenous RD
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01025934     History of Changes
Other Study ID Numbers: IVBDRNA
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: December 4, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
 Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents