Lucentis for New Onset Neovascular Glaucoma (NVG)
|ClinicalTrials.gov Identifier: NCT00727038|
Recruitment Status : Withdrawn (Company withdrew funding/sponsorship)
First Posted : August 1, 2008
Last Update Posted : July 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma New Onset Glaucoma Neovascular Glaucoma New Onset Neovascular Glaucoma||Drug: Ranibizumab (Lucentis)||Phase 1 Phase 2|
Intravitreal injection of Lucentis prior to conventional treatment for neovascular glaucoma improves overall outcome compared to conventional treatment alone.
To determine if pre-treatment with a single intravitreal injection of Lucentis prior to conventional treatment prevents severe vision loss and improves intraocular pressure control compared to conventional treatment alone.
Neovascular glaucoma is a potentially devastating consequence of fibrovascular proliferation of the anterior chamber angle with subsequent obstruction of the trabecular meshwork. The production of peripheral anterior synechiae along the trabecular meshwork leads to progressive angle closure. The subsequent elevation in intraocular pressure is difficult to manage, often leading to rapid progression of glaucoma and significant loss of vision. Enucleation for blind, painful eyes secondary to neovascular glaucoma is not an uncommon sequelae.
Neovascular glaucoma has many etiologic causes, the vast majority resulting from retinal ischemia secondary to relatively common diseases such as central retinal vein occlusion, proliferative diabetic retinopathy and ocular ischemic syndrome (carotid stenosis). (Sivac-Callcott et al., 2001) Vascular endothelial growth factor is likely a major contributor to the development of angle and iris neovascularization. (Ferrara, 2004) Although panretinal photocoagulation and/or cryoablation are mainstays of conventional treatment for neovascular glaucoma, the delayed therapeutic effect of these interventions often results in the formation of peripheral anterior synechiae and permanent angle closure.
Recent limited case series have demonstrated a role for bevacizumab (Avastin) in reducing rubeosis iridis and as an adjunct for neovascular glaucoma. (Grisanti et al., 2006; Davidorf et al., 2006; Iliev et al., 2006; Kahook, Schuman, Noecker, 2006) However, no prospective studies have examined the potential utility of anti-vascular endothelial growth factor agents in the treatment of neovascular glaucoma. Intravitreal Lucentis is the standard of care for the treatment of exudative macular degeneration. Pharmacologic agents such as Lucentis, which selectively inhibit vascular endothelial growth factor may provide an important therapeutic adjunct for the treatment of neovascular glaucoma by more immediately causing regression of angle neovascularization and thereby providing a window for permanent treatment with laser or cryotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of Lucentis in the Management of New Onset Neovascular Glaucoma|
Lucentis (ranibizumab) with conventional treatment
Drug: Ranibizumab (Lucentis)
0.5 mg ranibizumab intravitreal injection single dose administration
No Intervention: 2
- Mean change in best corrected visual acuity (BCVA) as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from baseline to Month 6. [ Time Frame: Baseline to Month 6. ]
- Percent change in angle neovascularization (measured in clock hours by gonioscopy). [ Time Frame: Initial visit through Month 6 ]
- Percent change in permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy). [ Time Frame: Initial visit through Month 6 ]
- Mean change in intraocular pressure measured by applanation tonometry. [ Time Frame: Initial visit through Month 6 ]
- Percent change in iris neovascularization (measured both in clock hours by slit lamp exam and with iris angiography). [ Time Frame: Initial visit through Month 6 ]
- Rates of severe vision loss (visual acuity <20/200, loss of 6 lines or more on ETDRS chart). [ Time Frame: Initial Visit through Month 6 ]
- Number of intraocular pressure lowering medications needed to control intraocular pressure. [ Time Frame: Initial Visit through Month 6 ]
- Mean change in optic nerve cupping. [ Time Frame: Initial Visit through Month 6 ]
- Percent of patients requiring surgical glaucoma procedure to control intraocular pressure (trabeculectomy, seton, or ciliary body destruction). [ Time Frame: Study duration ]
- Percent of patients requiring pars plana vitrectomy with endolaser. [ Time Frame: Study duration ]
- Rates of endophthalmitis. [ Time Frame: Study duration ]
- Rates of rhegmatogenous retinal detachment. [ Time Frame: Study duration ]
- Final clock hours of permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy) [ Time Frame: Month 6 visit ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727038
|Principal Investigator:||Michael P Blair, MD||University of Illinois at Chicago|