Clinical Trial: Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy (NAION)

Brief Summary: The purpose of this study is to explore the safety and efficacy of ranibizumab to treat non-arteritic ischemic optic neuropathy based on clinical and anatomical findings.

Detailed Summary:

Nonarteritic anterior ischemic optic neuropathy (NAION) is the most common acute optic neuropathy in people older than 50 years. It is characterized by sudden partial loss of vision in one eye and has an increased risk of vision loss in the fellow eye. Although cause has not been determined, NAION is thought to occur following an idiopathic ischemic event involving the short posterior ciliary arteries that supply blood to the most anterior part of the optic nerve. A complete loss of vision is rare, but partial loss of visual field or acuity can result from NAION in the affected eye(s).

Patients who have a 'disc at risk' or 'crowded disc' (small cup: disc ratio) are at increased risk for developing NAION. Other risk factors for NAION include age > 50 years and white race (estimated 95% of cases). Hypertension and diabetes also predispose to NAION development. Other factors that have been associated with NAION include high cholesterol, arteriosclerosis, stroke, cardiac and intraocular surgery, tobacco use, nocturnal hypotension, blood loss, glaucoma, elevated homocysteine and sleep apnea. The association between NAION and hypertension, high cholesterol and diabetes is stronger in individuals younger than 50 years than in older persons.

Patients with NAION caused by ischemia leading to swelling of the optic nerve and rapidly progressing visual loss have had limited results with therapy such as corticosteroids, brimonidine, levodopa or surgery, such as optic nerve sheath decompression, in the past. Currently, there is no standard of care for these patients.

Although the role of vascular endothelial growth factor (VEGF) in NAION has not been established, ischemic conditions may lead to VEGF production which could be the cause of edema and swelling. This possibility suggests t
Sponsor: University of Colorado, Denver

Current Primary Outcome: Change in Visual Acuity [ Time Frame: Baseline and 6 months ]

The mean change in best corrected Snellen visual acuity at 6 months in NAION patients treated as needed with ranibizumab.


Original Primary Outcome: To determine the mean change in best corrected visual acuity at 6 months in NAION patients treated as needed with ranibizumab. [ Time Frame: 6 months ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Mean change in VA at 3 months [ Time Frame: 3 months ]
  • percentage of patients that lose ≤ 15 letters at 6 months [ Time Frame: 6 months ]
  • percentage of patients gaining > 0 letters at 3 months and 6 months [ Time Frame: 6 months ]
  • percentage of patients with improvement in visual fields at 3 months, 6 months [ Time Frame: 6 months ]
  • percentage of patients with a resolution of edema on OCT at 3 months and at 6 months [ Time Frame: 6 months ]
  • Number of injections needed in 6 months [ Time Frame: 6 months ]
  • Evaluate ocular adverse events at 6 months [ Time Frame: 6 months ]


Information By: University of Colorado, Denver

Dates:
Date Received: November 19, 2007
Date Started: November 2007
Date Completion:
Last Updated: August 23, 2016
Last Verified: August 2016