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)?

Age-Related Macular Degeneration Clinical Trial

Official title:

Does VEGF or Complement Factor H Gene Polymorphism Play a Role in the Treatment Success With VEGF Inhibitors in Patients With CNV?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00813514
• Other study ID #: OPHT-270907
• Status: Withdrawn
• Phase: N/A
• First received: December 22, 2008
• Last updated: November 20, 2014
• Start date: January 2009
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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 been recently identified which is highly associated with an increased risk of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated to play a role in the development of the disease.

For this purpose a total of 200 patients with wet AMD will be included in the study. As described in detail below, the current study aims to identify potentially non-responders to anti-VEGF therapy based on genetic analysis of VEGF polymorphism and complement factor H polymorphism.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal NeoVascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Genetic:
• VEGF genotyping
blood sample for gene analysis

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity using ETDRS charts		2 x 5 minutes	No
Primary	Central retinal thickness (Optical coherence tomography)		2 x 20 minutes	No
Primary	VEGF genotyping		1 week	No