Recruiting
Phase 2

Bevacizumab

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT00813059

Conditions

Non-arteritic Anterior Ischemic Optic Neuropathy

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Intra-vitreal injection of bevacizumab (1.25mg/0.05ml)

Study Details

Brief summary:

Non-Arteritic Ischemic Optic Neuropathy (NAION) is a disease producing swelling of the optic nerve (the "cable" going from the eye to the brain) resulting in decreased vision. About 15% of patients will experience NAION in the second eye; many of these patients will be left legally blind.

Currently, there is no treatment for NAION and for patients in whom the second eye becomes involved by the disease the outcome can be devastating.

The investigators are conducting a study where the investigators will inject a medication into the involved eye of patients with NAION. This medication might decrease the swelling of the optic nerve and improve their vision in that eye.

Conditions

Non-arteritic Anterior Ischemic Optic Neuropathy

Study ID

NCT00813059

Start date

Feb, 2009

Status verified date

Feb, 2012

Completion date

Jun, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with newly diagnosed NAION (within the past 30 days but preferably within the first 14).

Exclusion Criteria:

  • Patients who are unable to give informed consent
  • Patient with:

  • uncontrolled glaucoma
  • pregnancy
  • lactation
  • proliferative diabetic retinopathy
  • active clinically significant diabetic macular edema
  • active uveitis
  • prior treatment with intraocular steroids that incited significant increase in intra-ocular pressure
  • other known causes of decreased visual acuity in the recently involved eye such as significant dry or wet macular degeneration
  • previous history of other optic neuropathies
  • previous history of ocular trauma that resulted in decreased visual acuity
  • Patients with baseline amblyopia in the newly involved eye and visual acuity worse than 20/50 prior to the onset of NAION
  • Previous treatment for any ocular condition with any investigational drugs

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Interventions

Intra-vitreal injection of bevacizumab (1.25mg/0.05ml)

Pars plana intra-vitreal injection of bevacizumab (1.25 mg/0.05 ml)

Primary outcome measure

  • Percentage of patients who gained three or more lines of vision at six months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Edward Margolin, MD

416-586-4800mjiharev@mtsinai.on.ca

Locations

Mount Sinai Hospital, University of Toronto

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Edward Margolin, MD

416-586-4800mjiharev@mtsinai.on.ca

Principal Investigator:

Edward Margolin, MD, FRSCS

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Feb 8, 2012

Last verified

Feb, 2012

Keywords

  • NAION
  • bevacizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2012-02-08.