A randomized, controlled, two-center phase II. study assessing the efficacy and safety of intravitreal Lucentis injections in patients with clinically significant macular edema secondary to central retinal vein occlusion.Randomizált, kontrollált, két központban végzett, II. fázisú klinikai vizsgálat a vena centralis retinae elzáródása következtében kialakult, klinikailag jelentos makula ödéma kezelésére használt intravitrealis Lucentis injekció hatékonyságának és biztonságosságának értékelésére - BRAVO
- Conditions
- Macular edema secondary to central retinal vein occlusionMedDRA version: 9.1Level: LLTClassification code 10007972Term: Central retinal vein occlusion
- Registration Number
- EUCTR2008-007175-24-HU
- Lead Sponsor
- niversity of Pécs, Medical School, Department of Ophthalmology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>;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. <br>;Primary end point(s): Mean change of BCVA tested by ETDRS chart compared to baseline in 12 months period.<br>
- Secondary Outcome Measures
Name Time Method