Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)
|Type 2 Idiopathic Macular Telangiectasia||Drug: Intravitreal injection ranibizumab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Ranibizumab in Idiopathic Macular Telangiectasia, Type 2. A Prospective Interventional Non-randomized Study Comparing the Efficacy and Safety of Intravitreal Ranibizumab in Type 2 Idiopathic Macular Telangiectasia.|
- Best corrected visual acuity [ Time Frame: one year ]
- Reading ability [ Time Frame: one year ]
- Scotomas measured by means of microperimetry [ Time Frame: one year ]
- Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging [ Time Frame: one year ]
- Changes in parafoveal leakage assessed by fluorescein angiography [ Time Frame: one year ]
- Quality of life [ Time Frame: one year ]
|Study Start Date:||August 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Drug: Intravitreal injection ranibizumab
Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year
Other Name: Lucentis
Type 2 idiopathic macular telangiectasia (type 2 IMT) is a retinal disease of unknown etiology that commonly presents with a slow decrease in visual acuity, reading difficulties and metamorphopsia in the fifth to seventh decade. Diagnosis is based on fluorescein angiography which typically reveals parafoveal leakage in the late phase and may show telangiectatic capillaries in the early phase. In a subset of patients, a proliferative stage with secondary neovascularizations may develop late in the disease course. In the past, there has been no effective treatment for the disease stages without neovascularization.
Recent studies in a limited number of patients with nonproliferative disease have shown promising results after intravitreal injection of bevacizumab, an antagonist targeting vascular endothelial growth factor (VEGF). Bevacizumab resulted in a decrease of parafoveal leakage in fluorescein angiography and a decrease in retinal thickness. An increase in visual acuity was reported in a subset of patients.
The RAMA-Trial is initiated in order to investigate the effect of a ranibizumab. The safety and tolerability of this VEGF-antagonist has been extensively studied in large cohorts of patients suffering from age-related macular degeneration.
Patients with type 2 IMT will receive monthly injections over a period of one year. The above mentioned outcome measures will be assessed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504400
|Department of Ophthalmology, University of Bonn|
|Principal Investigator:||Frank Holz, MD||University of Bonn, Department of Ophthalmology|
|Principal Investigator:||Hendrik PN Scholl, MD, MA||University of Bonn|