NCT01025934

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.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
Last Updated

December 4, 2009

Status Verified

December 1, 2009

First QC Date

December 3, 2009

Last Update Submit

December 3, 2009

Conditions

Study Arms (3)

7 days

ACTIVE COMPARATOR
Drug: Bevacizumab

20 days

ACTIVE COMPARATOR
Drug: Bevacizumab

sham

SHAM COMPARATOR
Other: sham

Interventions

20 days7 days
shamOTHER
sham

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • neovascular glaucoma
  • cataract
  • combined traction and rhegmatogenous RD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Bevacizumabsalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Last Updated

December 4, 2009

Record last verified: 2009-12