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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)?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Medical University of Vienna.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00813514
First received: December 22, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Choroidal Neovascularization
Age-Related Macular Degeneration
 Genetic: VEGF genotyping

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Does VEGF or Complement Factor H Gene Polymorphism Play a Role in the Treatment Success With VEGF Inhibitors in Patients With CNV?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Visual acuity using ETDRS charts [ Time Frame: 2 x 5 minutes ] [ Designated as safety issue: No ]
  • Central retinal thickness (Optical coherence tomography) [ Time Frame: 2 x 20 minutes ] [ Designated as safety issue: No ]
  • VEGF genotyping [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Open longitudinal study with observer masked analysis
 Genetic: VEGF genotyping
blood sample for gene analysis

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813514

Contacts
Contact: Gerhard Garhöfer, MD +431404002981

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Leopold Schmetterer, Prof. Dr. Department of Clinical Pharmacology
  More Information

No publications provided

Responsible Party: Dr. Fuchsjäger- Mayrl, Department of Clinical Pharmacology, Medical University Vienna, Austria
ClinicalTrials.gov Identifier: NCT00813514     History of Changes
Other Study ID Numbers: OPHT-270907
Study First Received: December 22, 2008
Last Updated: December 22, 2008
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
AMD
VEGF genotyping
complement H gene polymorphism
Vascular Endothelial Growth Factor A

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Complement System Proteins
 Complement Factor H
Mitogens
Endothelial Growth Factors
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013