Treatment of macular edema secondary to central or branch vein occlusion by dexamethazone intravitreal injection - Ozurdex in post-occlusive macular edema

Conditions: macular edema seconday to central or branch retinal vein occlusion
MedDRA version: 13.1Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disorders

Registration Number: EUCTR2011-000425-72-IT

Lead Sponsor: IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Macular edema with a duration <12 months 2. Central retinal vein occlusion 3. Branch retinal vein occlusion 4. Best correct visual acuity (BCVA) in the study eye = 20/400 4. Central retinal thickness = 250 micron by OCT
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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures