Polypoidal Choroidal Vasculopathy Clinical Trial
Official title:
Off-Label Use of AVASTIN (BEVACIZUMAB)Intravitreal Injection For the Treatment of Serosanguinous Maculopathy
To assess the use of Avastin for the management of serosanguinous maculopathy
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | May 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Singapore National Eye Centre |
Michels S, Rosenfeld PJ, Puliafito CA, Marcus EN, Venkatraman AS. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration twelve-week results of an uncontrolled open-label clinical study. Ophthalmology. 2005 Jun;112(6):1035-47. — View Citation
Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in OCT measured central retinal thickness | |||
Secondary | Correlation in change in central retinal thickness and change in VA |
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