Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

This study has been completed.

Sponsor:

Collaborator:

Napoli CTO Hospital

Information provided by:

Second University of Naples

ClinicalTrials.gov Identifier:

NCT01025934

First received: December 3, 2009

Last updated: NA

Last verified: December 2009

History: No changes posted

Purpose

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	Intervention	Phase
Proliferative Diabetic Retinopathy	Drug: Bevacizumab Other: sham	Phase 4


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Second University of Naples:

Arms	Assigned Interventions
Active Comparator: 7 days	Drug: Bevacizumab
Active Comparator: 20 days	Drug: Bevacizumab
Sham Comparator: sham	Other: sham

Eligibility


Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided by Second University of Naples

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

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.


ClinicalTrials.gov Identifier:	NCT01025934 History of Changes
Other Study ID Numbers:	IVBDRNA
Study First Received:	December 3, 2009
Last Updated:	December 3, 2009
Health Authority:	Italy: Ethics Committee

Additional relevant MeSH terms:


Diabetic Retinopathy Retinal Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Vascular Diseases	Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents Growth Inhibitors Growth Substances Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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