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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2006-006233-40 |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal injection ranibizumab | Drug | Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year |
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| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Reading ability | one year | |
| Scotomas measured by means of microperimetry | one year | |
| Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Holz, MD | University of Bonn, Department of Ophthalmology | Principal Investigator |
| Hendrik PN Scholl, MD, MA | University of Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, University of Bonn | Bonn | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21334595 | Derived | Charbel Issa P, Finger RP, Kruse K, Baumuller S, Scholl HP, Holz FG. Monthly ranibizumab for nonproliferative macular telangiectasia type 2: a 12-month prospective study. Am J Ophthalmol. 2011 May;151(5):876-886.e1. doi: 10.1016/j.ajo.2010.11.019. Epub 2011 Feb 19. | |
| 20877651 | Derived | Charbel Issa P, Troeger E, Finger R, Holz FG, Wilke R, Scholl HP. Structure-function correlation of the human central retina. PLoS One. 2010 Sep 22;5(9):e12864. doi: 10.1371/journal.pone.0012864. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| one year |
| Changes in parafoveal leakage assessed by fluorescein angiography | one year |
| Quality of life | one year |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |