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Avastin for Post-Photocoagulation Macular Edema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801866
First Posted: December 4, 2008
Last Update Posted: December 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asociación para Evitar la Ceguera en México
  Purpose
to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision

Condition Intervention Phase
Macular Edema Drug: Bevacizumab Procedure: Panretinal Photocoagulation Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Prevention of Post-Photocoagulation Macular Edema by Intravitreal Bevacizumab.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Best Corrected Visual Acuity

Secondary Outcome Measures:
  • Central Retinal Thickness.

Arms Assigned Interventions
Experimental: Group 1
Panretinal Photocoagulation + Bevacizumab
Drug: Bevacizumab
Intravitreal administration
Experimental: Group 2
Panretinal Photocoagulation
Procedure: Panretinal Photocoagulation
Panretinal Photocoagulation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Proliferative retinopathy or severe non-proliferative retinopathy
  • BCVA of 20/63 or better (56 ETDRS letters
  • No history of Macular Edema
  • Central Retinal Thickness of 250mics or more

Exclusion Criteria:

  • Previous treatment.
  • Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy
  • Media opacities
  Contacts and Locations
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): NCT00801866


Locations
Mexico
Asociación para Evitar la Ceguera en México
Mexico, DF, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Study Director: Eduarto Torres-Porras, MD Asociación para Evitar la Ceguera en México
Principal Investigator: Octavio Burgos, MD Asociación para Evitar la Ceguera en México
  More Information

ClinicalTrials.gov Identifier: NCT00801866     History of Changes
Other Study ID Numbers: APEC-035
First Submitted: December 3, 2008
First Posted: December 4, 2008
Last Update Posted: December 4, 2008
Last Verified: December 2008

Keywords provided by Asociación para Evitar la Ceguera en México:
Panretinal Photocoagulation
Macular Edema
Intravitreal Bevacizumab

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
Growth Inhibitors
Antineoplastic Agents