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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001727-19-IT

Enrollment

Registered

2006-12-04

Start date

2006-10-03

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

exudative maculopathy MedDRA version: 8.1 Level: LLT Classification code 10038862 Term: Retinal exudates

Interventions

Trade Name: KENACORT*3FL 1ML 40MG/ML Pharmaceutical Form: Suspension for injection Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.;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;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.	—

Measure

Time frame

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.;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;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.

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Countries

Italy

Outcome results

None listed

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