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Intravitreal Bevacizumab for Retinal Disorders

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Narayana Nethralaya.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403026
First Posted: November 23, 2006
Last Update Posted: November 23, 2006
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:
Narayana Nethralaya
  Purpose
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 Intervention
Wet AMD Macular Oedema Proliferative Diabetic Retinopathy Drug: Bevacizumab ( Avastin)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Narayana Nethralaya:

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

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

Estimated Enrollment: 150
Study Start Date: August 2006
Estimated Study Completion Date: November 2006
  Show Detailed Description

  Eligibility

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
Criteria

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.
  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): NCT00403026


Contacts
Contact: sivakami pai, MS 91-80-23373311 ext 27 shivsudhir@gmail.com
Contact: shubha anil 91-80-23373311 ext 33 info@narayananethralaya.com

Locations
India
Sivakami Pai Recruiting
Bangalore, India, 560010
Contact: sivakami pai, MS    91-80-23373311 ext 27    shivsudhir@gmail.com   
Principal Investigator: SIVAKAMI PAI, MS         
Sponsors and Collaborators
Narayana Nethralaya
Investigators
Principal Investigator: sivakami pai, MS Narayana Nethralaya, Bangalroe, India
  More Information

ClinicalTrials.gov Identifier: NCT00403026     History of Changes
Other Study ID Numbers: NN-002/2006
First Submitted: November 22, 2006
First Posted: November 23, 2006
Last Update Posted: November 23, 2006
Last Verified: November 2006

Keywords provided by Narayana Nethralaya:
Bevacizumab (Avastin)
Intravitreal injection
VEGF
CRVO
BRVO
PDR
CNVM

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
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents