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WithdrawnNCT00417716Updated Jun 3, 2024

Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

A Phase 3 interventional study of Intravitreal Bevacizumab in Diabetes Mellitus Type 2 and Diabetic Macular Edema, sponsored by Asociación para Evitar la Ceguera en México. Withdrawn at 1 site in Mexico. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Asociación para Evitar la Ceguera en México · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Poor accrual

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Sep 2005, registered Jun 2006).
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
45 Years and older
Sex
All
01

Study summary

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

Read the detailed description

A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.

02

Conditions studied

  • Diabetes Mellitus Type 2
  • Diabetic Macular Edema

Keywords

  • Diffuse Diabetic Macular Edema
  • Intravitreal Bevacizumab
  • Anti-VEGF drugs
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

Browse Macular Edema studies →

Lead sponsor

Asociación para Evitar la Ceguera en México is the lead sponsor of 58 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • DrugIntravitreal Bevacizumab
06

What researchers measure

Primary outcomes

  1. BCVA

  2. Fluorescein Angiography

  3. Optical Coherence Tomography

07

Study locations

1 site
  • Asociación para Evitar la Ceguera en México
    Mexico city, Distrito Federal 04030, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00417716
Lead sponsor
Asociación para Evitar la Ceguera en México
First posted
Jan 4, 2007
Start date
Sep 2005
Primary completion
Sep 2005
Completion
May 2006
Last update
Jun 3, 2024

Study contacts

Adriana Solís-Vivanco, MD
principal investigator · Asociación para Evitar la Ceguera en México
Jans Fromow-Guerra, MD PhD
study chair · Asociación para Evitar la Ceguera en México
Elizabeth Reyna-Castelán
study chair · Asociación para Evitar la Ceguera en México
Juan M Jiménez-Sierra, MD
study chair · Asociación para Evitar la Ceguera en México
Myriam Hernández-Rojas, MD
study chair · Asociación para Evitar la Ceguera en México
Griselda Alvarez-Rivera, MD
study chair · Asociación para Evitar la Ceguera en México
Hugo Quiroz-Mercado, MD
study director · Asociación para Evitar la Ceguera en México
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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