NCT01041690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2010

Completed
Last Updated

January 1, 2010

Status Verified

January 1, 2007

Enrollment Period

1 year

First QC Date

December 31, 2009

Last Update Submit

December 31, 2009

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic RetinopathyVitrectomyBevacizumab

Outcome Measures

Primary Outcomes (1)

  • Intra- and post-operative bleedings were recorded.

    3 months

Secondary Outcomes (1)

  • Best Corrected Visual Acuity

    3 months

Study Arms (1)

Bevacizumab

EXPERIMENTAL
Drug: Bevacizumab

Interventions

BevacizumabDRUG
Also known as: Avastin
Bevacizumab

Eligibility Criteria

Age9 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Tractional Retinal Detachment involving or threatening the macula,
  • Tractional+Rhegmatogenous Retinal Detachment, or
  • Fibrovascular tissue covering and distorting the macula.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department Of Ophthalmology

Cairo, Cairo Governorate, 11221, Egypt

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 31, 2009

First Posted

January 1, 2010

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 1, 2010

Record last verified: 2007-01

Locations

EG(1)