Off-Label AVASTIN (BEVACIZUMAB) For Serosanguinous Maculopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Singapore National Eye Centre.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00344617
First received: June 23, 2006
Last updated: September 25, 2007
Last verified: September 2007
  Purpose

To assess the use of Avastin for the management of serosanguinous maculopathy


Condition Intervention Phase
Choroidal Neovascularisation
Polypoidal Choroidal Vasculopathy
Drug: Bevacizumab (tradename: Avastin)
Phase 3

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 Use of AVASTIN (BEVACIZUMAB)Intravitreal Injection For the Treatment of Serosanguinous Maculopathy

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • 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:
  • Change in OCT measured central retinal thickness
  • Correlation in change in central retinal thickness and change in VA

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Study Completion Date: May 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00344617

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

Publications:
ClinicalTrials.gov Identifier: NCT00344617     History of Changes
Other Study ID Numbers: R452/01/2006
Study First Received: June 23, 2006
Last Updated: September 25, 2007
Health Authority: Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority

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

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

ClinicalTrials.gov processed this record on October 21, 2014