Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy

Nonarteritic Anterior Ischemic Optic Neuropathy Clinical Trial

— NAION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561834
• Other study ID #: 07-0446
• Secondary ID: genentech FVF425
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2007
• Last updated: October 22, 2012
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: October 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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 that VEGF may be a target for therapeutic intervention by ranibizumab. Ranibizumab has demonstrated an effect on edema and vascular permeability. In animal studies it has shown a concentration- dependent effect of blunting the vascular permeability induced by VEGF. Of the more than 5,000 subjects with age-related macular degeneration in current and completed clinical trials, vascular permeability and edema have decreased with the use of ranibizumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• provide written informed consent

• 21 years of age or older

• new onset, within 14 days, of ischemia and vision loss

• Best Corrected Visual Acuity (BCVA) 20/40 or worse

Exclusion Criteria:

• pregnancy or lactation

• patients with proliferative diabetic retinopathy, diabetic macular edema, uveitis, history of ocular trauma, severe glaucoma, age-related macular degeneration

• prior or concomitant treatment of oral steroids within 30 days, participation in any studies of investigational drugs within 30 days, participation in a ranibizumab clinical trial or prior treatment intravitreally or intravenously of Avastin or steroids.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Nonarteritic Anterior Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Drug:
• ranibizumab
0.5mg ranibizumab given intravitreally as needed after initial treatment

Locations

Country	Name	City	State
United States	Rocky Mountain Lions Eye Institute	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the mean change in best corrected visual acuity at 6 months in NAION patients treated as needed with ranibizumab.		6 months	No
Secondary	Mean change in VA at 3 months		3 months	No
Secondary	percentage of patients that lose = 15 letters at 6 months		6 months	No
Secondary	percentage of patients gaining > 0 letters at 3 months and 6 months		6 months	No
Secondary	percentage of patients with improvement in visual fields at 3 months, 6 months		6 months	No
Secondary	percentage of patients with a resolution of edema on Ocular Coherence Tomography (OCT) at 3 months and at 6 months		6 months	No
Secondary	Number of injections needed in 6 months		6 months	No
Secondary	Evaluate ocular adverse events at 6 months		6 months	Yes