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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004487-53-IT
Enrollment
Unknown
Registered
2007-10-12
Start date
2007-12-13
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exudative and atrophic age-related macular degeneration. MedDRA version: 6.1 Level: PT Classification code 10025409

Interventions

Trade Name: MACUGEN*INIET 1 SIR 0,3MG Pharmaceutical Form: Solution for injection INN or Proposed INN: PEGAPTANIB SODICO Concentration unit: µg microgram(s) Concentration type: equal Concentration nu

Sponsors

AZIENDA OSPEDALIERA PISANA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026