Type 2 Idiopathic Macular Telangiectasia Clinical Trial
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.
The purpose of this study is to investigate if a new drug called ranibizumab is effective to treat a rare bilateral disease of the macula: type 2 idiopathic macular telangiectasia (type 2 IMT). 10 patients will receive monthly injections of the drug into one eye over a period of one year.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment