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)?

NCT00813514 | Withdrawn

• 1 other identifier: OPHT-270907
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Choroidal NeoVascularization; Age-Related Macular Degeneration

Keywords

AMD; VEGF genotyping; complement H gene polymorphism; Vascular Endothelial Growth Factor A

Outcome Measures

Primary Outcomes (3)

• Visual acuity using ETDRS charts

  2 x 5 minutes

• Central retinal thickness (Optical coherence tomography)

  2 x 20 minutes

• VEGF genotyping

  1 week

Study Arms (1)

1

EXPERIMENTAL

Open longitudinal study with observer masked analysis

Genetic: VEGF genotyping

Interventions

VEGF genotyping GENETIC

blood sample for gene analysis

1

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Active intraocular inflammation
• Acute angle-closure glaucoma or narrow angle glaucoma due to the risk of IOP elevation caused by the administration of tropicamide

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Study Officials

• Leopold Schmetterer, Prof. Dr.

  Department of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: January 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

AU (1)