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Proliferative ischemic retinopathies lead to a formation of abnormal vessels on the iris surface induced by an increased level of vascular endothelial growth factor (VEGF). In progressive stages fibrovascular membranes occlude the anterior chamber angle which inhibits aqueous outflow resulting in neovascular glaucoma. The increased intraocular pressure is often difficult to control and frequently results in loss of vision.
The aim of this study is to analyze the short- and long-term outcome after adjuvant intraocular Ranibizumab application in patients with neovascular glaucoma and rubeosis and to analyze the role of ranibizumab within a holistic treatment regime.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis (Ranibizumab) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5mg intraocular Ranibizumab (Lucentis) | Drug | short- and long-term effects of 0.5mg intraocular Ranibizumab (Lucentis) injections as adjuvant for patients with rubeosis and neovascular glaucoma |
| Measure | Description | Time Frame |
|---|---|---|
| change of degree of iris rubeosis | Main outcome measure is the change of degree of iris rubeosis as documented by iris fluorescein angiography as measured 12 months after the first ranibizumab injection. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in intraocular pressure | • to document changes in intraocular pressure measurements with the Goldmann applanation tonometer | 12 Months |
| changes in best corrected visual acuity (BCVA) | • to document changes in best corrected visual acuity (BCVA) measured on 4 meters |
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Inclusion Criteria:
neo-vascular glaucoma or rubeosis
an available follow-up of 12 months
written informed consent
visual acuity of light perception or better.
Exclusion Criteria:
Ocular concomitant conditions/ diseases
Compliance/ Administrative
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Grisanti, M.D. Prof. | University of Lübeck - Department of Ophthalmology: Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lübeck - Department of Ophthalmology | Lübeck | 23538 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23893090 | Derived | Luke J, Nassar K, Luke M, Grisanti S. Ranibizumab as adjuvant in the treatment of rubeosis iridis and neovascular glaucoma--results from a prospective interventional case series. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2403-13. doi: 10.1007/s00417-013-2428-y. Epub 2013 Jul 28. |
| Label | URL |
|---|---|
| University of Lübeck - Department of Ophthalmology - Germany | View source |
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| ID | Term |
|---|---|
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye 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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| 12 Months |
| numbers of additional interventions | • to document numbers of additional interventions or anti-glaucomatous medications 12 months after injection | 12 Months |
| quality of life | • to document changes of quality of life | 12 Months |
| Number of adverse events in all participants | • to evaluate the safety of intravitreal injections of ranibizumab (0.5 mg) as adjunctive in patients with rubeosis and neovascular glaucoma using the number of adverse events. | 12 Months |
| changes in gonioscopy | • to document changes in gonioscopy of the anterior chamber angle | 12 Months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |