Intravitreal Bevacizumab for Retinal Disorders

November 22, 2006 updated by: Narayana Nethralaya

Off-Label,Intravitreal Use of Bevacizumab for Retinal Disorders

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Purpose: To study the efficacy and safety of invitreal injection of bevacizumab (avastin) in all the following conditions.

  • 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
  • Informed consent were taken from all the patients, based on the guidelines of OMIC (Ophthalmic mutual insurance company)Avastin: Risk management recommendations and consent form.

American Academy of ophthalmology-Risk management recommendations for off-label , Intravitreal use of Avastin.

Included indications, exclusion criteria, possible complications and the off-label status of the drug.

Best corrected visual acuity, Fundus Photography, anterior segment examination, Optical coherence tomography and in selected patients Electrophysiology, VEP and Fundus fluorescein angiography was done according to surgeons discretion.

All the patients were examined on day 1, 1st week and subsequently depending on the surgeons discretion and tests were performed during follow ups.

During follow up best-corrected visual acuity, anterior and posterior segment examination. Fundus photography, Intraocular pressure and OCT was repeated and in selected patients FFA, ERG,and VEP was done, physicians follow up was done.

Preparation of the Drug:

Bevacizumab Avastin (Avastin) comes in a sterile vial (100 mg in 4 ml) preservative free and ensure safety the vial injection was within a day.

Injections were given with 30 gauge needle, tuberculin syringes single use. 0.05ml containing 1.25 mg drug was given intravitreally under all aseptic precautions under topical anaesthesia,suggested by Flynn , Harry w.and scott, Ingrid u. -Evolving guidelines for intravitreous injections.

Following the injection topical antibiotics was given for 1 week.

Design: Prospective interventional non randomised case series.

Informed consent process

Informed consent was taken in English and the patients were explained in their local language by the treating surgeon.

The Food and Drug Administration approved Avastin for the treatment of metastatic Colorectal cancer. It is the first humanized Anti-VEGF antibody, which prevents angiogenesis. Since the drug is FDA approved the off-label drug is used for Intravitreal usage. For other purposes if patients are well-informed about the product, base, its use on firm scientific method and sound medical evidence, and maintain records of its use and effects. Ophthalmologists are using Avastin "off-label" to treat AMD and similar conditions since research indicates that VEGF is one of the causes for the growth of the abnormal vessels that cause these conditions. All the patients were informed about the "off-label" status, which is not FDA approved. Similar to kenalog, which is FDA approved but the off-label drug is used as Intravitreal injection to treat eye conditions.

Study Type

Interventional

Enrollment

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Bangalore, India, 560010
        • Recruiting
        • Sivakami Pai
        • Contact:
        • Principal Investigator:
          • SIVAKAMI PAI, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Vision change
Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness)
Electrophysiological changes (ERG, VEP)

Secondary Outcome Measures

Outcome Measure
Ocular side effects (infection, RD, IOP rise, cataract)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Narayana Nethralaya

Investigators

  • Principal Investigator: sivakami pai, MS, Narayana Nethralaya, Bangalroe, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

November 23, 2006

Last Update Submitted That Met QC Criteria

November 22, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN-002/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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