This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Information provided by:
Narayana Nethralaya Identifier:
First received: November 22, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
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: 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


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00403026     History of Changes
Other Study ID Numbers: NN-002/2006
Study First Received: November 22, 2006
Last Updated: November 22, 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 processed this record on June 23, 2017