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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra-CT: 2008-004675-22 |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).
Pigment epithelial detachments (PED) secondary to age-related macular degeneration (AMD) have been excluded from practically all study populations of ranibizumab studies so far. PED represents a special entity in AMD. As yet, no standard treatment has been established for this disease.The stimuli that induce PED are not very well known, but there is evidence suggesting that angiogenic factors such as vascular endothelial growth factor (VEGF) also play a role in the pathogenesis. Ranibizumab is an anti-VEGF antibody fragment that blocks VEGF activity in patients with neovascular AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Arm Ranibizumab | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravitreal injection with ranibizumab | Drug | 0.5 mg in 0.05 ml, monthly, 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 12 months | |
| Mean change in best corrected visual acuity | 12 months | |
| Change in retinal thickness and height of pigment epithelial detachment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Eter, MD | Dept. of Ophthalmology, University of Muenster Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Muenchen | München | 80336 | Germany | |||
| University Hospital Muenster |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28084038 | Derived | Clemens CR, Wolf A, Alten F, Milojcic C, Heiduschka P, Eter N. Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study. Acta Ophthalmol. 2017 Nov;95(7):683-689. doi: 10.1111/aos.13359. Epub 2017 Jan 13. |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D058449 | Intravitreal Injections |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| 12 months |
| Central visual field and stability of fixation | 12 months |
| Fluorescein leakage and changes in autofluorescence | 12 months |
| Münster |
| 48149 |
| Germany |
| D013812 |
| Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |