Pilot study of association of VEGF polymorphisms with clinical efficacy and tolerability of therapy in patients affected by exudative (neovascular) age-related macular degeneration. - DEGENE

• Conditions: Exudative and atrophic age-related macular degeneration.; MedDRA version: 6.1Level: PTClassification code 10025409

• Registration Number: EUCTR2007-004487-53-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a. Patients affected by exudative age-related macular degeneration with a diagnosis made by fluoroangiography; b. Patients affected by atrophic age-related macular degeneration with a diagnosis made by fluoroangiography or without any vitreoretinic pathology; c. Patients candidates to a photodynamic and antiangiogenic therapy affecte by exudative age-related macular degeneration; d. Proper renal functionality; e. Proper hepatic functionality; f. Proper bone marrow functionality; g. Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Pregnancy or breast-feeding; b. Age < 30 years; c. Previous vitreoretinic surgery; d. Diabetes; e. Asthma; f. Neoplastic diseases except cervical intra-epithelial and skin neoplasia ; g. Psoriasis; h. Systemic Lupus Erythematosus; i. Rheumatoid arthritis; l. Impossibility of carrying out a suitable follow up.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To analyse possible correlations between VEGF genotype results and the efficacy/tolerability of photodynamic or antiangiogenic treatment (pegaptanib e ranibizumab).;Primary end point(s): a. Genetic analysis with methods of molecular biology; b. Univariate/multivariate statistical analysis of the results.;Main Objective: To evaluate and compare VEGF polymorphisms in patients affected by exudative and atrophic age-related macular degeneration, and control patients.