Status:

UNKNOWN

Off-Label AVASTIN (BEVACIZUMAB) For Serosanguinous Maculopathy

Lead Sponsor:

Singapore National Eye Centre

Conditions:

Choroidal Neovascularisation

Polypoidal Choroidal Vasculopathy

Eligibility:

All Genders

50+ years

Phase:

PHASE3

Brief Summary

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

Detailed Description

METHODOLOGY Patients will be recruited from the vitreoretinal clinics at SNEC. After initial assessment, clinically and angiographically, the patient will be counselled with regards to diagnosis, pro...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2008

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00344617

Start Date

June 1 2006

End Date

May 1 2008

Last Update

September 26 2007

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