neovascular age-related macular degeneration MedDRA version: 9.1 Level: LLT Classification code 10025409 Term: Macular degeneration
Conditions
Interventions
Trade Name: ALFAFERONE*1F 1000000UI 1ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon alfa natural
Concentration unit: IU international unit(s)
Concentration type: equal
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: neovascular age-related macular degeneration confiremd by FAG+ and OCT Age > 18 years 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: Treatments with Photodynamic therapy or other antiangiogenic agent Treatments with systemic interferon or steroids Diabetes, depression, psychosis Women during pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to examine the action of Interferon 2 as anti-angiogenic agent for the treatment of neovascular age-related macular degeneration;Secondary Objective: The secondary objectives of this study are to evaluate the macular edema, the CNV dimension and safety of Interferon 2 treatment;Primary end point(s): Visual acuity measured with ETDRS scale | — |
Countries
Italy
Outcome results
None listed