Triamcinolone Acetonide Intravitreal Injection for the treatment for exudative maculopathy - ND

• Conditions: exudative maculopathy; MedDRA version: 8.1Level: LLTClassification code 10038862Term: Retinal exudates

• Registration Number: EUCTR2006-001727-19-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Age 18 years Male and Female patients affected by secondary macular oedema due to retinal central vein occlusion, by macular oedema due to diabetes, uveitis, coroidal neovascularization connected with AMD, vitreo-retinal proliferation, by macular oedema consequent to phacoemulsification, to neovascular glaucoma, to telangiectasia, by macular oedema connected with retinitis pigmentosa or with age-related maculopathy.
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

Women who are pregnant or breastfeeding Clinical history of chronic ocular incfections Clinical history of Glaucoma

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the project is to evaluate efficacy and safety of triamcinolone acetonide intravitreal injection by means of functional and structural analysis of the retina.;Primary end point(s): The aim of the project is to evaluate efficacy and safety of triamcinolone acetonide intravitreal injection by means of functional and structural analysis of the retina.;Secondary Objective: The project will make provision for 40 patients affected by secondary macular oedema due to retinal central vein occlusion, by macular oedema due to diabetes, uveitis, coroidal neovascularization connected with AMD, vitreo-retinal proliferation, by macular oedema consequent to phacoemulsification, to neovascular glaucoma, to telangiectasia, by macular oedema connected with retinitis pigmentosa or with age-related maculopathy