Lucentis for New Onset Neovascular Glaucoma (NVG)

This study has been withdrawn prior to enrollment.
(Company withdrew funding/sponsorship)
Sponsor:
Collaborator:
Genentech
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00727038
First received: July 29, 2008
Last updated: July 26, 2010
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Glaucoma
New Onset Glaucoma
Neovascular Glaucoma
New Onset Neovascular Glaucoma
Drug: Ranibizumab (Lucentis)
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Arms Assigned Interventions
Experimental: 1
Lucentis (ranibizumab) with conventional treatment
Drug: Ranibizumab (Lucentis)
0.5 mg ranibizumab intravitreal injection single dose administration
Other Names:
  • ranibizumab
  • Lucentis
No Intervention: 2
Conventional treatment

Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 21 years
  • Diagnosis of neovascular glaucoma (angle neovascularization with or without iris neovascularization and IOP > 21 mm Hg and > 5 mm Hg IOP compared to the fellow eye).
  • Neovascular glaucoma secondary to retinal ischemia (central retinal vein occlusion, proliferative diabetic retinopathy, ocular ischemic syndrome, etc.)

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Prior enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  • > 270 degrees of closed trabecular meshwork (closure secondary to peripheral anterior synechiae)
  • History of active inflammatory, infectious, or idiopathic keratitis precluding view of the anterior segment structures.
  • Previous intravitreal injections of ranibizumab or bevacizumab in either eye.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727038

Sponsors and Collaborators
University of Illinois at Chicago
Genentech
Investigators
Principal Investigator: Michael P Blair, MD University of Illinois at Chicago
  More Information

Additional Information:
Publications:
Responsible Party: Michael Blair, MD, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00727038     History of Changes
Other Study ID Numbers: FVF4143S
Study First Received: July 29, 2008
Last Updated: July 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Illinois at Chicago:
glaucoma
neovascular glaucoma
new onset glaucoma
retinal ischemia
central retinal vein occlusion
proliferative diabetic retinopathy
ocular ischemic syndrome
carotid stenosis
vascular endothelial growth factor
neovascular

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on October 01, 2014