Off-Label AVASTIN (BEVACIZUMAB) For Serosanguinous Maculopathy

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. Identifier: NCT00344617
Recruitment Status : Unknown
Verified September 2007 by Singapore National Eye Centre.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2006
Last Update Posted : September 26, 2007
Information provided by:
Singapore National Eye Centre

Brief Summary:
To assess the use of Avastin for the management of serosanguinous maculopathy

Condition or disease Intervention/treatment Phase
Choroidal Neovascularisation Polypoidal Choroidal Vasculopathy Drug: Bevacizumab (tradename: Avastin) Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Off-Label Use of AVASTIN (BEVACIZUMAB)Intravitreal Injection For the Treatment of Serosanguinous Maculopathy
Study Start Date : June 2006
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Primary Outcome Measures :
  1. Change from baseline in VA, i.e. gain or loss of 5 letters (1 line), 15 letters (3 lines) or 30 letters (6 lines)

Secondary Outcome Measures :
  1. Change in OCT measured central retinal thickness
  2. Correlation in change in central retinal thickness and change in VA

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. All subfoveal/juxtafoveal CNV and PCV (polypoidal choroidal vasculopathy) who are not eligible for other treatment options (compassionate use)
  2. CNV and PCV lesions which have failed PDT, conventional argon laser photocoagulation (salvage use)
  3. CNV and PCV lesions treatable with PDT, but cannot afford or refused

Exclusion Criteria:

  1. Patients with uncontrolled hypertension (systolic BP greater than 150mmHg or diastolic BP greater than 90mmHg
  2. History of thrombolic events such as myocardial infarction or cerebral vascular accident
  3. Renal abnormalities (as defined by established history of chronic renal disease or renal failure as well as patients requiring dialysis).
  4. Recent (as defined as the past 28 days) or planned (as defined as the next 3 months) surgery.
  5. Coagulation abnormalities, including anti-coagulant medication other than aspirin
  6. Patients with peptic ulcer disease
  7. Pregnant or lactating females

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 identifier (NCT number): NCT00344617

Sponsors and Collaborators
Singapore National Eye Centre
Principal Investigator: Chong-Lye Ang, FRCOphth Singapore National Eye Centre

Publications: Identifier: NCT00344617     History of Changes
Other Study ID Numbers: R452/01/2006
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: September 26, 2007
Last Verified: September 2007

Keywords provided by Singapore National Eye Centre:
Choroidal neovascularisation
Polypoidal choroidal vasculopathy
Intravitreal injection

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Vascular Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Cardiovascular Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents