Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01041690
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Reports of the use of intravitreal bevacizumab (Avastin, Genentech) for the reduction of neovascularization in proliferative diabetic retinopathy have demonstrated significant regression in the number of new vessels. Reducing the vascularity of neovascular fibrovascular tissue can potentially reduce bleeding intraoperatively and thus facilitate the vitrectomy procedure. The investigators chose to investigate the potential benefit of the use of preoperative bevacizumab in the management of these most complex cases.

Condition or Disease	Intervention/Treatment	Phase
Proliferative Diabetic Retinopathy	Drug: Bevacizumab	N/A

Detailed Description

PURPOSE: To evaluate the role of preoperative intravitreal bevacizumab as an adjunct to vitrectomy in the management of severe diabetic eye disease.

SETTINGS: Kasr El-Aini Teaching Hospital - Cairo University from 2007 to 2008. METHODS:

Twenty eyes of 19 patients with severe proliferative diabetic retinopathy were recruited into the study. All eyes underwent a single intravitreal injection of bevacizumab 1.25 mg in 0.05 ml one week prior to vitrectomy for tractional (14), combined tractional/rhegmatogenous retinal detachment (4), and fibrovascular tissue covering/distorting the macula (2). Exclusion criteria were: previous vitrectomy, neovascular glaucoma, and dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA) that was done pre- and 1 week post injections. Best corrected visual acuity (BCVA), anterior segment with dilated fundus examinations, and intraocular pressures (IOP), were done pre-, 1 week post-injections, 1 day, 1 week and monthly for 3 months post-vitrectomy. Intra- and post-operative bleedings were recorded.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bevacizumab (Avastin) as an Adjunct to Vitrectomy in the Management of Severe Proliferative Diabetic Retinopathy: a Prospective Case Series
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bevacizumab	Drug: Bevacizumab; Other Names: Avastin

Outcome Measures

Primary Outcome Measures

1. Intra- and post-operative bleedings were recorded. [3 months]

Secondary Outcome Measures

1. Best Corrected Visual Acuity [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Tractional Retinal Detachment involving or threatening the macula,

• Tractional+Rhegmatogenous Retinal Detachment, or

• Fibrovascular tissue covering and distorting the macula.

Exclusion Criteria:

• Vitrectomy

• Neovascular glaucoma

• Dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department Of Ophthalmology	Cairo		Egypt	11221

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01041690
• Other Study ID Numbers: Beva-Cairo-A1
• First Posted: Jan 1, 2010
• Last Update Posted: Jan 1, 2010
• Last Verified: Jan 1, 2007

• Keywords provided by , ,: Proliferative Diabetic Retinopathy; Vitrectomy; Bevacizumab
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Bevacizumab

Study Results

No Results Posted as of Jan 1, 2010