Cystoid macular edema in uveitis MedDRA version: 9.1 Level: LLT Classification code 10051240 Term: Cystoid macular edema MedDRA version: 9.1 Level: LLT Classification code 10046851 Term: Uveitis
Conditions
Interventions
Trade Name: KENACORT*INIET 3FL 1ML 40MG/ML
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Triamcinolone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a history of chronic anterior uveitis, intermediate uveitis or panuveitis with CME and without signs of acute ocular inflammation will be included 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: Patients showing infectious uveitis, severe media opacities, diabetes, other maculopathies, steroid responders or patients with IOP equal or superior to 21 mmHg and pregnant women will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is to assess the efficacy of sub-Tenon anti-inflammatory therapy (triamcinolone acetonide 40 mg) in patients affected by CME secondary to uveitis.;Secondary Objective: Secondary objective is to establish the relationship between OCT morphologic data and perimetric functional parameters.;Primary end point(s): n.d. | — |
Countries
Italy
Outcome results
None listed