NCT00524875

Brief Summary

The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
Last Updated

September 5, 2007

Status Verified

August 1, 2007

First QC Date

September 4, 2007

Last Update Submit

September 4, 2007

Conditions

Diabetic Retinopathy

Keywords

Proliferative diabetic retinopathyBevacizumabEarly post-vitrectomy vitreous hemorrhage

Outcome Measures

Primary Outcomes (1)

  • early post-vitrectomy vitreous hemorrhage

Secondary Outcomes (1)

  • Visual improvement

Study Arms (2)

1

EXPERIMENTAL

Intravitreal bevacizumab injection 1-2 weeks before surgery

Drug: Bevacizumab

2

SHAM COMPARATOR

Sham injection (needleless syringe pressed against conjunctiva)

Drug: Bevacizumab

Interventions

BevacizumabDRUG

One dose of bevacizumab (1.25 mg/0.05 cc) one to two weeks before pars plana vitrectomy for diabetic retinopathy

12

Eligibility Criteria

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

You may qualify if:

  • All eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive PDR

You may not qualify if:

  • One eye patient
  • Best corrected visual acuity better than 20/50
  • Pregnancy
  • Use of internal tamponade such as silicone oil during surgery
  • Concurrent ophthalmic surgery such as cataract extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamid Ahmadieh, MD

Tehran, Tehran Province, 16666, Iran

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Hamid Ahmadieh, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamid Ahmadieh, MD

CONTACT

+98 21 22585952hahmadieh@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 5, 2007

Study Start

January 1, 2007

Study Completion

September 1, 2007

Last Updated

September 5, 2007

Record last verified: 2007-08

Locations

IR(1)