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Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT00571142
Recruitment Status : Unknown
Verified December 2007 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
First Posted : December 11, 2007
Last Update Posted : December 11, 2007
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México

Brief Summary:
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 or disease Intervention/treatment Phase
* Diffuse Diabetic Macular Edema Procedure: Bevacizumab + Pars plana vitrectomy Procedure: Bevacizumab + pars plana vitrectomy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)
Study Start Date : November 2007
Estimated Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Retinal thickness [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: December 11, 2007
Last Verified: December 2007

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
Temazepam
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action