Macular structure and function after intravitreal injection of bevacizumab for wet macular degeneration a interventional study. - ND

• Conditions: Macular degeneration; MedDRA version: 6.1Level: PTClassification code 10025409

• Registration Number: EUCTR2005-006014-18-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Exudative age related macular degeneration age 60 and visual acuity between FC finger count and 0,5 decimal ETDRS table . The location of choroidal neovascularization CNV should be subfoveal either classic 4 disc diameter, minimally classic CNV or occult CNV, as well as RAP lesions more than II stage, lesions with large haemorrhagic component, large pigment epithelial detachments PED . Are also included in the study patients that are not eligible for photodinamic therapy PDT because they do not accomplish the PDT treatment criteria low vision, presence of disciform scar , or because they refuse PDT or other treatment for the cure of their pathology.
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

Patients with exudative age related macular degeneration with classic CNV 4 disc diameter. Patients with exudative maculopathy CNV not related to age related macular degeneration such as pathologic myopia, inflammation, angioid streaks. Patients with media opacity in which is not possible to evaluate the details the fundus of the eye

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess macular structure and function by visual acuity ETDRS , optical coherence tomography OCT3 , focal electroretinogram FERG , microperimetry, fluorescein and indocyanine angiography before and after intravitreal bevacizumab administration for wet age related macular degeneration.;Secondary Objective: To assess macular structure and function by visual acuity ETDRS , optical coherence tomography OCT3 , focal electroretinogram FERG , microperimetry, fluorescein and indocyanine angiography before and after intravitreal bevacizumab administration for wet age related macular degeneration.;Primary end point(s): To reduct the maculare degeneration and to improve the visual acuity ETDRS