Status:
WITHDRAWN
Does Vascular Endothelial Growth Factor (VEGF) or Complement Factor H Gene Polymorphism Play a Role in the Treatment Success With VEGF Inhibitors in Patients With Choroidal NeoVascularization (CNV)?
Lead Sponsor:
Medical University of Vienna
Conditions:
Choroidal NeoVascularization
Age-Related Macular Degeneration
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Most importantly a genetic polymorphism in the gene encoding for the complement factor H (CFH) has b...
Eligibility Criteria
Inclusion
- Men and women aged over 50 years
- Angiographically verified neovascular AMD
- Active primary or recurrent subfoveal lesion with CNV secondary to AMD
- Activity to be proven by fluorescein angiography
- Best corrected visual acuity assessed using ETDRS charts of 20/40 to 20/320 in the study eye
- CNV to be treated with intravitreal ranibizumab
- Signed informed consent
Exclusion
- Prior treatment with any intravitreal drug in the study eye
- Prior treatment with verteporfin photodynamic therapy in the study eye
- Prior treatment with systemic bevacizumab
- Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the non-study eye within the 3 moths before the study entry
- Laser photocoagulation within 1 month before study entry in the study eye
- Previous participation in any clinical trial within 1 month before the entry of the study
- Subfoveal fibrosis or atrophy in the study eye
- CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia
- Retinal pigment epithelial tear involving the macula in the study eye
- Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
- Active intraocular inflammation
- Acute angle-closure glaucoma or narrow angle glaucoma due to the risk of IOP elevation caused by the administration of tropicamide
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00813514
Start Date
January 1 2009
End Date
November 1 2014
Last Update
November 21 2014
Active Locations (1)
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1
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria