NCT00370721

Brief Summary

To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in cases with the signs of active progressive PDR

Trial Health

55
Monitor

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Last Updated

June 26, 2008

Status Verified

June 1, 2008

First QC Date

August 30, 2006

Last Update Submit

June 25, 2008

Conditions

Diabetic Retinopathy

Keywords

Proliferative diabetic retinopathy(PDR)Pan retinal photocoagulation (PRP)Vitreous hemorrhageTraction retinal detachmentNeovascularization on disc (NVD)Neovascularization elsewhere (NVE)Fibrous proliferation on disc (FPD)Fibrous proliferaiton elsewhere (FPE)

Outcome Measures

Primary Outcomes (2)

  • Regression of diabetic retinopathy

  • visual acuity

Secondary Outcomes (5)

  • neovascularization

  • fibrous proliferation

  • traction retinal detachment

  • vitreous hemorrhage

  • pan retinal photocoagulation

Study Arms (1)

I

EXPERIMENTAL
Drug: bevacizumab

Interventions

bevacizumabDRUG
I

Eligibility Criteria

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

You may qualify if:

  • Cases of active progressive PDR with history of scatter laser photocoagulation

You may not qualify if:

  • history of vitrectomy

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 RetinopathyVitreous Hemorrhage

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesEye HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

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
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

March 1, 2006

Last Updated

June 26, 2008

Record last verified: 2008-06

Locations

IR(1)