Macular edema secondary to central retinal vein occlusion MedDRA version: 9.1 Level: LLT Classification code 10007972 Term: Central retinal vein occlusion
Conditions
Sponsors
University of Pécs, Medical School, Department of Ophthalmology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Macular edema persisting for more than 3 months period despite conventional medication listed above. Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG). Patients randomized into ranibizumab-treated group do not receive macular laser treatment. Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 µm and/or retinal thickness is above 330 µm at any region of the macula calculated by retinal thickness analysis. Baseline visual acuity is less than 78 ETDRS letters (or 20/32 Snellen equivalent). 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: Diabetes mellitus Additional vitreoretinal diseases History of pars plana vitrectomy Previous macular grid laser treatment Intravitreal triamcinolone acetonid treatment Complicated cataract surgery Advanced glaucomatous damage of optic nerve head Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract) Age-related macular degeneration Pregnancy and lactation Women in childbearing potential who are not using double safe contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: To assess the superiority of intravitreal (IVT) ranibizumab to conventional treatment concerning prevention of visual loss or improvement of BCVA as determined by the mean change of BCVA tested by ETDRS chart compared to baseline in 12 months period, when intravitreal ranibizumab is applied monthly in the first 3 months period, and later when visual acuity (VA) decreases with more than 5 letters at any visit performed monthly. ;Secondary Objective: Secondary objectives: The efficacy of treatment concerning change of anatomical structure of macular region detected by Optical Coherence Tomography (OCT) – the mean change of macular thickness (micron) at each months of 1 year period. ;Primary end point(s): Mean change of BCVA tested by ETDRS chart compared to baseline in 12 months period. | — |
Countries
Hungary
Outcome results
None listed