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
Recruitment status was Recruiting
Sponsor:
Asociación para Evitar la Ceguera en México
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
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
Drug Information available for:
Bevacizumab
U.S. FDA Resources
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
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 | Asociacion para Evitar la Ceguera en Mexico |
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 Temazepam Bevacizumab Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013