Intravitreal Bevacizumab for Retinal Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Narayana Nethralaya.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Narayana Nethralaya
ClinicalTrials.gov Identifier:
NCT00403026
First received: November 22, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
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

  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
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 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

No publications provided

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

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014