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Intravitreal Bevacizumab for Retinal Disorders
This study is currently recruiting participants.
Verified by Narayana Nethralaya, November 2006
Sponsored by: Narayana Nethralaya
Information provided by: Narayana Nethralaya
ClinicalTrials.gov Identifier: NCT00403026
  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)

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders
Drug Information available for: Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Off-Label,Intravitreal Use of Bevacizumab for Retinal Disorders

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers: NN-002/2006
Study First Received: November 22, 2006
Last Updated: November 22, 2006
ClinicalTrials.gov Identifier: NCT00403026  
Health Authority: India: Institutional Review Board

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

Study placed in the following topic categories:
Eye Diseases
Vascular Diseases
Diabetes Mellitus
Edema
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Bevacizumab
Diabetic Angiopathies
Macular Edema
Diabetic Retinopathy
Endocrinopathy
Retinal Diseases
Diabetes Complications
Retinal degeneration

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009