Study to Evaluate the Effects of Ranibizumab (Lucentis) for Patients With Rubeosis and Neovascular Glaucoma (LucNVG0108)
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Prospective, Monocenter, Prove of Concept Study to Evaluate the Short- and Long-term Effects of 0.5mg Intraocular Ranibizumab (Lucentis) Injections as Adjuvant for Patients With Rubeosis and Neovascular Glaucoma|
- change of degree of iris rubeosis [ Time Frame: 12 Months ]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.
- changes in intraocular pressure [ Time Frame: 12 Months ]• to document changes in intraocular pressure measurements with the Goldmann applanation tonometer
- changes in best corrected visual acuity (BCVA) [ Time Frame: 12 Months ]• to document changes in best corrected visual acuity (BCVA) measured on 4 meters
- numbers of additional interventions [ Time Frame: 12 Months ]• to document numbers of additional interventions or anti-glaucomatous medications 12 months after injection
- quality of life [ Time Frame: 12 Months ]• to document changes of quality of life
- Number of adverse events in all participants [ Time Frame: 12 Months ]• 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.
- changes in gonioscopy [ Time Frame: 12 Months ]• to document changes in gonioscopy of the anterior chamber angle
|Study Start Date:||November 2008|
|Study Completion Date:||July 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
|Experimental: Lucentis (Ranibizumab)||
Drug: 0.5mg intraocular Ranibizumab (Lucentis)
short- and long-term effects of 0.5mg intraocular Ranibizumab (Lucentis) injections as adjuvant for patients with rubeosis and neovascular glaucoma
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370135
|University of Lübeck - Department of Ophthalmology|
|Lübeck, Germany, 23538|
|Principal Investigator:||Salvatore Grisanti, M.D. Prof.||University of Lübeck - Department of Ophthalmology: Germany|