Intravitreal Bevacizumab for Retinal Disorders

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. Identifier: NCT00403026
Recruitment Status : Unknown
Verified November 2006 by Narayana Nethralaya.
Recruitment status was:  Recruiting
First Posted : November 23, 2006
Last Update Posted : November 23, 2006
Information provided by:
Narayana Nethralaya

Brief Summary:
Bevacizumab is an anti-VEGF agent used in approved for use in metastatic colorectal carcinoma (FDA Approved). This study analyzes the safety and efficacy of off-label Intravitreal Injection of bevacizumab (Avastin) for CNVM, Macular oedema due to diabetic retinopathy, vascular occlusion and other retinal disorders.

Condition or disease Intervention/treatment Phase
Wet AMD Macular Oedema Proliferative Diabetic Retinopathy Drug: Bevacizumab ( Avastin) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Off-Label,Intravitreal Use of Bevacizumab for Retinal Disorders
Study Start Date : August 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Primary Outcome Measures :
  1. Vision change
  2. Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness)
  3. Electrophysiological changes (ERG, VEP)

Secondary Outcome Measures :
  1. Ocular side effects (infection, RD, IOP rise, cataract)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
  • Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
  • Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
  • Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.

Exclusion Criteria:

  • Patients with poor compliance
  • Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients).
  • Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.

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 identifier (NCT number): NCT00403026

Contact: sivakami pai, MS 91-80-23373311 ext 27
Contact: shubha anil 91-80-23373311 ext 33

Sivakami Pai Recruiting
Bangalore, India, 560010
Contact: sivakami pai, MS    91-80-23373311 ext 27   
Principal Investigator: SIVAKAMI PAI, MS         
Sponsors and Collaborators
Narayana Nethralaya
Principal Investigator: sivakami pai, MS Narayana Nethralaya, Bangalroe, India Identifier: NCT00403026     History of Changes
Other Study ID Numbers: NN-002/2006
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: November 23, 2006
Last Verified: November 2006

Keywords provided by Narayana Nethralaya:
Bevacizumab (Avastin)
Intravitreal injection

Additional relevant MeSH terms:
Macular Edema
Diabetic Retinopathy
Retinal Diseases
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents