Back to results

Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%

Primary Purpose

Optic Neuropathy, Ischemic, Anterior Ischemic Optic Neuropathy, Ischemic Optic Neuropathy

Status

Withdrawn

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Timolol maleate

About this trial

This is an interventional treatment trial for Optic Neuropathy, Ischemic focused on measuring Ischemic, Optic Neuropathy, Non-Arteritic Anterior Ischemic Optic Neuropathy, NAION, Ischemic Optic Neuropathy, Intraocular Pressure

Eligibility Criteria

41 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age >40
Sudden, painless monocular vision loss with edema of the optic disc
Clinical diagnosis is Non-Arteritic Anterior Ischemic Optic Neuropathy
Relative Afferent Pupil Defect (RAPD) at first study visit

Exclusion Criteria:

Onset of vision loss >48 hours from time of enrollment
History of Asthma or COPD
History of Heart Block or Sinus Bradycardia
Allergy to any beta blocker
History of Multiple Sclerosis or optic neuropathy
Active Ocular Inflammation on examination
Currently being treated for Cancer or systemic vasculitis
History of Glaucoma or use of medications that lower IOP
Symptomatic cataract, retinopathy, macular disease or amblyopia in the symptomatic eye
IOP of <10 at baseline
Ocular surgery in past three months
Women who are pregnant, breast-feeding or may become pregnant
Inability to provide informed consent or follow up at three months
Currently enrolled in any other study drug trial or previously enrolled in this study

Sites / Locations

Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Timolol

Standard Care

Arm Description

This group will receive ophthalmic Timolol maleate 0.5%, 1 drop to the effected eye twice daily for 4 weeks.

This group will be treated with current standard care. This does not include Timolol or other medications to reduce intraocular pressure.

Outcomes

Primary Outcome Measures

Recruitment Rate of patients during the one year study to assess feasibility of a larger study

This is to define the feasabilty of the study design for a larger study.

Number of patients with adverse events

Secondary Outcome Measures

Change in visual acuity at enrollment and three month follow up using a logMAR scale.

This will evaluate the change in visual acuity as a measure of visual function.

Change in the mean deviation of actual versus predicted sensitivity of the visual field.

Using a a Haag-Streit Octopus 900 with white on white TOP 30-2 visual field program, the mean deviation will be compared at various time points to assess for improving visual function as it relates to the field of vision.

Change in Colour vision as measured by HRR colour plates.

The total number of colour plates seen will be counted and compared to baseline as a measure of visual recovery as it effects colour vision.

Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart.

The Pelli-Robson contrast sensitivity chart is another method to assess visual function. The change in total number of plates seen will be compared at the various time points.

Full Information

NCT ID

NCT01607671

First Posted

May 25, 2012

Last Updated

May 22, 2015

Sponsor

Fraser Health

1. Study Identification

Unique Protocol Identification Number

NCT01607671

Brief Title

Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%

Official Title

Can Urgent Reduction of Intraocular Pressure With Ophthalmic Timolol Improve Recovery From Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): a Randomized Study.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to recruit participants from recruiting sites.

Study Start Date

June 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fraser Health

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the feasibility of rapid evaluation and administration of ophthalmic Timolol maleate in the treatment of non-arteritic anterior ischemic optic neuropathy. Secondary goals are to evaluate if such treatment reduces the progression or improves recovery of patients who are randomly assigned to treatment versus standard of care.

Detailed Description

Non-arteritic anterior ischemic optic neuropathy (NAION) currently has no widely accepted acute treatment to improve recovery or prevent progression in the first month. It causes monocular vision loss with potential second eye involvement in 15% at 5 years. This leads to significant disability. It is the most common acute optic neuropathy in patients over 55 years of age. The final mechanism of injury is believed to be ischemic. Increasing perfusion of the optic nerve may reduce damage and prevent progression. Reduction in intraocular pressure has been shown to increase optic disc perfusion in animal models. Timolol maleate is a widely used medication for Glaucoma that reduces intraocular pressure. Treatment with Timolol maleate may improve optic disc perfusion in NAION and reduce ischemic damage from this condition. This study aims to enroll and treat patients with Timolol maleate 0.5% within 48 hours of symptom onset to assess feasibility of the study design and potential benefit of rapid intraocular pressure reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Optic Neuropathy, Ischemic, Anterior Ischemic Optic Neuropathy, Ischemic Optic Neuropathy, Optic Neuropathy, Anterior Ischemic

Keywords

Ischemic, Optic Neuropathy, Non-Arteritic Anterior Ischemic Optic Neuropathy, NAION, Ischemic Optic Neuropathy, Intraocular Pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Timolol

Arm Type

Experimental

Arm Description

This group will receive ophthalmic Timolol maleate 0.5%, 1 drop to the effected eye twice daily for 4 weeks.

Arm Title

Standard Care

Arm Type

No Intervention

Arm Description

This group will be treated with current standard care. This does not include Timolol or other medications to reduce intraocular pressure.

Intervention Type

Drug

Intervention Name(s)

Timolol maleate

Other Intervention Name(s)

Timoptic., Timolol., Timolol maleate.

Intervention Description

Timolol 0.5% 1 drop twice daily to the effected eye for 4 weeks.

Primary Outcome Measure Information:

Title

Recruitment Rate of patients during the one year study to assess feasibility of a larger study

Description

This is to define the feasabilty of the study design for a larger study.

Time Frame

12 months

Title

Number of patients with adverse events

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in visual acuity at enrollment and three month follow up using a logMAR scale.

Description

This will evaluate the change in visual acuity as a measure of visual function.

Time Frame

Enrolment, Within 48 hours of enrollment , 1 month, 3 months.

Title

Change in the mean deviation of actual versus predicted sensitivity of the visual field.

Description

Time Frame

48 hours after enrollment, 1 month, 3 months

Title

Change in Colour vision as measured by HRR colour plates.

Description

The total number of colour plates seen will be counted and compared to baseline as a measure of visual recovery as it effects colour vision.

Time Frame

Within 48 hours of enrollment, 1 month, 3 months

Title

Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart.

Description

The Pelli-Robson contrast sensitivity chart is another method to assess visual function. The change in total number of plates seen will be compared at the various time points.

Time Frame

48 hours from enrollment, 1 month, 3 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

41 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >40 Sudden, painless monocular vision loss with edema of the optic disc Clinical diagnosis is Non-Arteritic Anterior Ischemic Optic Neuropathy Relative Afferent Pupil Defect (RAPD) at first study visit Exclusion Criteria: Onset of vision loss >48 hours from time of enrollment History of Asthma or COPD History of Heart Block or Sinus Bradycardia Allergy to any beta blocker History of Multiple Sclerosis or optic neuropathy Active Ocular Inflammation on examination Currently being treated for Cancer or systemic vasculitis History of Glaucoma or use of medications that lower IOP Symptomatic cataract, retinopathy, macular disease or amblyopia in the symptomatic eye IOP of <10 at baseline Ocular surgery in past three months Women who are pregnant, breast-feeding or may become pregnant Inability to provide informed consent or follow up at three months Currently enrolled in any other study drug trial or previously enrolled in this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin A SuttonBrown, MD

Organizational Affiliation

Fraser Health Region

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3T 0G9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

20006051

Citation

Atkins EJ, Bruce BB, Newman NJ, Biousse V. Treatment of nonarteritic anterior ischemic optic neuropathy. Surv Ophthalmol. 2010 Jan-Feb;55(1):47-63. doi: 10.1016/j.survophthal.2009.06.008.

Results Reference

background

PubMed Identifier

8361399

Citation

Glucksberg MR, Dunn R. Direct measurement of retinal microvascular pressures in the live, anesthetized cat. Microvasc Res. 1993 Mar;45(2):158-65. doi: 10.1006/mvre.1993.1015.

Results Reference

background

PubMed Identifier

1623958

Citation

Maepea O. Pressures in the anterior ciliary arteries, choroidal veins and choriocapillaris. Exp Eye Res. 1992 May;54(5):731-6. doi: 10.1016/0014-4835(92)90028-q.

Results Reference

background

PubMed Identifier

16151785

Citation

Wilhelm B, Ludtke H, Wilhelm H; BRAION Study Group. Efficacy and tolerability of 0.2% brimonidine tartrate for the treatment of acute non-arteritic anterior ischemic optic neuropathy (NAION): a 3-month, double-masked, randomised, placebo-controlled trial. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):551-8. doi: 10.1007/s00417-005-0102-8. Epub 2005 Sep 8.

Results Reference

background

PubMed Identifier

7844872

Citation

Optic nerve decompression surgery for nonarteritic anterior ischemic optic neuropathy (NAION) is not effective and may be harmful. The Ischemic Optic Neuropathy Decompression Trial Research Group. JAMA. 1995 Feb 22;273(8):625-32.

Results Reference

background

Learn more about this trial

Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%

We'll reach out to this number within 24 hrs