Cystoid macular oedema due to branch retinal vein occlusion
Conditions
Interventions
Trade Name: LUCENTIS 10MG/ML DFL
Product Name: Ranibizumab
Pharmaceutical Form: Solution for injection
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male or female, at least 18 years of age. - ophthalmoscopic evidence of recent BRVO, that is, a history of 3 months. - macular edema secondary to BRVO in the study eye scheduled for intravittreal anti-VEGF as primary treatment. - retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline. - VA decrease attributable to the edema. - written informed consent has been obtained. - female patients of childbearing potential must have a negative urine pregnancy test. 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: - Uncontrolled sytemic disease - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Any ocular condition that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia) - History of glaucoma, aphakie or presence of anterior chamber intraocular lens, active reinal neovascularisation, choroidal neovascularisation, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study perios. - contraindication to pupil dilation known allergy or contraindication to the use of fluorescein. - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main outcome measure: Retinal vessel diameters;Secondary Objective: Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with Microperimetry, objective functional response assessed with mfERG, anatomic changes in the macula region as assessed with StratusOCT and prototype of a Cirrus-OCT(which is available at the Department of Ophthalmology, Medical University of Vienna), angiographical outcomes. ;Primary end point(s): | — |
Countries
Austria
Outcome results
None listed