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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)?

Primary Purpose

Choroidal NeoVascularization, Age-Related Macular Degeneration

Status

Withdrawn

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

VEGF genotyping

Sponsored by

Medical University of Vienna

About this trial

This is an interventional diagnostic trial for Choroidal NeoVascularization focused on measuring AMD, VEGF genotyping, complement H gene polymorphism, Vascular Endothelial Growth Factor A

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Open longitudinal study with observer masked analysis

Outcomes

Primary Outcome Measures

Visual acuity using ETDRS charts

Central retinal thickness (Optical coherence tomography)

VEGF genotyping

Secondary Outcome Measures

Full Information

NCT ID

First Posted

December 22, 2008

Last Updated

November 20, 2014

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00813514

Brief Title

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)?

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Withdrawn

Study Start Date

January 2009 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Choroidal NeoVascularization, Age-Related Macular Degeneration

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

Open longitudinal study with observer masked analysis

Intervention Type

Genetic

Intervention Name(s)

VEGF genotyping

Intervention Description

blood sample for gene analysis

Primary Outcome Measure Information:

Title

Visual acuity using ETDRS charts

Time Frame

2 x 5 minutes

Title

Central retinal thickness (Optical coherence tomography)

Time Frame

2 x 20 minutes

Title

VEGF genotyping

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leopold Schmetterer, Prof. Dr.

Organizational Affiliation

Department of Clinical Pharmacology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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)?

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