NCT00813059

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

3.3 years

First QC Date

December 19, 2008

Last Update Submit

February 6, 2012

Conditions

Non-arteritic Anterior Ischemic Optic Neuropathy

Keywords

NAIONbevacizumab

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who gained three or more lines of vision at six months

    6 months

Study Arms (1)

1

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

Interventions

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

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

1

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital, University of Toronto

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Related Publications (3)

  • Bennett JL, Thomas S, Olson JL, Mandava N. Treatment of nonarteritic anterior ischemic optic neuropathy with intravitreal bevacizumab. J Neuroophthalmol. 2007 Sep;27(3):238-40. doi: 10.1097/WNO.0b013e31814b273d. No abstract available.

    PMID: 17895825BACKGROUND

  • Kelman SE. Intravitreal triamcinolone or bevacizumab for nonarteritic anterior ischemic optic neuropathy: do they merit further study? J Neuroophthalmol. 2007 Sep;27(3):161-3. doi: 10.1097/WNO.0b013e31814a61ae. No abstract available.

    PMID: 17895813BACKGROUND

  • Fung AE, Rosenfeld PJ, Reichel E. The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. Br J Ophthalmol. 2006 Nov;90(11):1344-9. doi: 10.1136/bjo.2006.099598. Epub 2006 Jul 19.

    PMID: 16854824BACKGROUND

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Edward Margolin

    Mount Sinai Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Margolin, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

February 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations

CA(1)