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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
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Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born children, characterized by the development of retinal neovascularisation, macular dragging and eventually retinal detachment. ROP is a leading cause for childhood blindness, especially in developing countries. Vascular endothelial growth factor (VEGF) plays an important role in the development of the disease. Recently, the BEAT ROP study tested the efficacy of intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled, randomized, stratified, multicenter trial. Authors found that bevacizumab showed a significant benefit for Zone I but not Zone II disease, with continuation of peripheral retinal vessel growths after treatment. The authors also concluded that safety could not be assessed due to the small sample size. Other authors raised concerns regarding the results of the BEAT ROP study and the safety of bevacizumab.
The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single injection of ranibizumab.
The outcome of six eyes with ROP stage 3 plus treated with one single intravitreal injection of ranibizumab is presented. Safety issues and side affects are discussed. Follow up was 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental | All eyes receive one intravitreal injection with 0.03ml ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravitreal injection of 0.03ml ranibizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of eyes with ocular side effects due to intravitreal ranibizumab | assessment of direct ocular adverse events due to intravitreal ranibizumab injections as a measure of safety | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with systemic side effects of intravitreal ranibizumab | number of patients with systemic side effects as a measure of safety. | 6 months |
| efficacy of intravitreal ranibizumab to treat ROP stage 3 plus |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Inselspital | Bern | Canton of Bern | 3001 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25886603 | Derived | Menke MN, Framme C, Nelle M, Berger MR, Sturm V, Wolf S. Intravitreal ranibizumab monotherapy to treat retinopathy of prematurity zone II, stage 3 with plus disease. BMC Ophthalmol. 2015 Mar 8;15:20. doi: 10.1186/s12886-015-0001-7. |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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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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Assessment of the regression of ROP-related changes due to treatment as a measure for efficacy
| 6 months |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |