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)?

Medical University of Vienna

Status

Withdrawn

Conditions

Age-Related Macular Degeneration

Choroidal NeoVascularization

Treatments

Genetic: VEGF genotyping

Study type

Interventional

Funder types

Other

Identifiers

NCT00813514

OPHT-270907

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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