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Avastin for Post-Photocoagulation Macular Edema

This study has been completed.
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00801866
First received: December 3, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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:

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:
  • Best Corrected Visual Acuity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central Retinal Thickness. [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00801866     History of Changes
Other Study ID Numbers: APEC-035
Study First Received: December 3, 2008
Last Updated: December 3, 2008
Health Authority: Mexico: Ministry of Health

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013