NCT00417716

Brief Summary

Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

June 30, 2006

Last Update Submit

May 31, 2024

Conditions

Diabetes Mellitus Type 2Diabetic Macular Edema

Keywords

Diffuse Diabetic Macular EdemaIntravitreal BevacizumabAnti-VEGF drugs

Outcome Measures

Primary Outcomes (3)

  • BCVA

  • Fluorescein Angiography

  • Optical Coherence Tomography

Interventions

Intravitreal BevacizumabDRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Macular edema involving the center of the macula demonstrated on OCT
  • Clear ocular media
  • Untreated patients
  • Older than 45 years
  • BCVA of the fellow eye at least 20/100

You may not qualify if:

  • Renal diabetic disease, uncontrolled hypertension or stroke history
  • Other ocular disease
  • Ocular surgery excepting uncomplicated phacoemulsification
  • History of photocoagulation (panretinal or focal)
  • History of another intravitreal treatment (like triamcinolone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación para Evitar la Ceguera en México

Mexico City, Mexico City, 04030, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Adriana Solís-Vivanco, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

  • Jans Fromow-Guerra, MD PhD

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • Elizabeth Reyna-Castelán

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • Juan M Jiménez-Sierra, MD

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • Myriam Hernández-Rojas, MD

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • Griselda Alvarez-Rivera, MD

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR

  • Hugo Quiroz-Mercado, MD

    Asociación para Evitar la Ceguera en México

    STUDY DIRECTOR
0

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

June 30, 2006

First Posted

January 4, 2007

Study Start

September 1, 2005

Primary Completion

September 1, 2005

Study Completion

May 1, 2006

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations

ME(1)