Clinical Trial: Lucentis for New Onset Neovascular Glaucoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Randomized Controlled Trial of Lucentis in the Management of New Onset Neovascular Glaucoma

Brief Summary: 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.

Detailed Summary:

Hypothesis:

Intravitreal injection of Lucentis prior to conventional treatment for neovascular glaucoma improves overall outcome compared to conventional treatment alone.

Specific Aims:

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.

R
Sponsor: University of Illinois at Chicago

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Illinois at Chicago

Dates:
Date Received: July 29, 2008
Date Started:
Date Completion:
Last Updated: July 26, 2010
Last Verified: July 2008