macular edema seconday to central or branch retinal vein occlusion MedDRA version: 13.1 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: OZURDEX
Pharmaceutical Form: Ophthalmic insert
INN or Proposed INN: Dexamethasone
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 700-
Sponsors
IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Macular edema with a duration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any other ocular condition that might permanently impair the visual acuity in study eye including amblyopia, anterior ischemic optic neuropathy 2. Previous surgery in the study eye, such also cataract extraction, within 3 months before the study 3. any intravitreal injection in the study eye including Ozurdex injection or anti-VEGF drugs within 4 months before the enrollment 4. Pregnancy or breast-feeding 5. Advanced glaucoma 6. Active ocular or periocular infection 7.any ocular allergies versus active drugs or excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate morphological and functional retinal changes after Ozurdex intravitreal injection;Secondary Objective: Safety of the treatment and need to be retreated;Primary end point(s): improvement in visual acuity | — |
Countries
Italy
Outcome results
None listed