Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00571142
First received: December 7, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease.


Condition Intervention Phase
* Diffuse Diabetic Macular Edema
Procedure: Bevacizumab + Pars plana vitrectomy
Procedure: Bevacizumab + pars plana vitrectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • Retinal thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2007
Estimated Study Completion Date: February 2008
Arms Assigned Interventions
Active Comparator: 1
Renal disease
Procedure: Bevacizumab + Pars plana vitrectomy
2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.
Active Comparator: 2
Without renal disease
Procedure: Bevacizumab + pars plana vitrectomy
2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 25 yo
  • Diffuse diabetic macular edema with or without previous treatment

Exclusion Criteria:

  • Another retinal disease
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571142

Contacts
Contact: Veronica Kon-Jara, MD 5215537291895 veronicakon@yahoo.com
Contact: Antonieta Burgoa 10841400 ext 1171 retinamex@yahoo.com

Locations
Mexico
Asociacion para Evitar la Ceguera en Mexico I.A.P. Recruiting
Mexico, Mexico, 04030
Sub-Investigator: Ma Ana Martinez-Castellanos, MD         
Sub-Investigator: Oscar Alvarez-Verduzco, MD         
Sub-Investigator: Jose Luis Guerrero-Naranjo, MD         
Sub-Investigator: Hugo Quiroz-Mercado, MD         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Veronica Kon-Jara, MD Asociación para Evitar la Ceguera en México
  More Information

No publications provided

Responsible Party: Veronica Kon-Jara MD, Asociacion para Evitar la Ceguera en Mexico I.A.P.
ClinicalTrials.gov Identifier: NCT00571142     History of Changes
Other Study ID Numbers: APEC-ret
Study First Received: December 7, 2007
Last Updated: December 7, 2007
Health Authority: Mexico: Subsecretary of Ministry of Health, Mexico city

Keywords provided by Asociación para Evitar la Ceguera en México:
edema
retinal thickness
diabetic retinopathy

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014