Lucentis for New Onset Neovascular Glaucoma (NVG)
Neovascular glaucoma is a potentially debilitating disease of the eye. Vascular eye disease such as diabetes and vein occlusions can cause the retina to release factors that promote the growth of abnormal blood vessels. These abnormal vessels can grow in the drainage mechanism of the eye causing pressure in the eye to markedly increase. This can potentially cause irreversible damage to the optic nerve from glaucoma leading to permanent blindness and painful eyes. Conventional treatments including laser and freezing therapy take weeks to cause regression in abnormal blood vessel growth. This delay often results in permanent vision loss and pain. New medications targeted at more immediately reducing blood vessel growth may aid in the treatment of this disease.
New Onset Glaucoma
New Onset Neovascular Glaucoma
Drug: Ranibizumab (Lucentis)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial of Lucentis in the Management of New Onset Neovascular Glaucoma|
- 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. ] [ Designated as safety issue: Yes ]
- Percent change in angle neovascularization (measured in clock hours by gonioscopy). [ Time Frame: Initial visit through Month 6 ] [ Designated as safety issue: Yes ]
- Percent change in permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy). [ Time Frame: Initial visit through Month 6 ] [ Designated as safety issue: Yes ]
- Mean change in intraocular pressure measured by applanation tonometry. [ Time Frame: Initial visit through Month 6 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Number of intraocular pressure lowering medications needed to control intraocular pressure. [ Time Frame: Initial Visit through Month 6 ] [ Designated as safety issue: Yes ]
- Mean change in optic nerve cupping. [ Time Frame: Initial Visit through Month 6 ] [ Designated as safety issue: Yes ]
- Percent of patients requiring surgical glaucoma procedure to control intraocular pressure (trabeculectomy, seton, or ciliary body destruction). [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
- Percent of patients requiring pars plana vitrectomy with endolaser. [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
- Rates of endophthalmitis. [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
- Rates of rhegmatogenous retinal detachment. [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
- Final clock hours of permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy) [ Time Frame: Month 6 visit ] [ Designated as safety issue: Yes ]
Lucentis (ranibizumab) with conventional treatment
Drug: Ranibizumab (Lucentis)
0.5 mg ranibizumab intravitreal injection single dose administration
No Intervention: 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.