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Optic Neuropathy, IschemicPhase 1NCT01607671

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

A Phase 1 study testing Timolol maleate in people with Optic Neuropathy, Ischemic and Anterior Ischemic Optic Neuropathy, run by Fraser Health at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 41 years and older
What is being tested?
Timolol maleate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Jun 2012to Nov 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 41 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology

    Surrey, British Columbia, V3T 0G9

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Timolol maleate
Keywords
Ischemic, Optic Neuropathy, Non-Arteritic Anterior Ischemic Optic Neuropathy, NAION, Ischemic Optic Neuropathy, Intraocular Pressure
Medical subject headings
Optic Neuropathy, Ischemic, Ischemia, Optic Nerve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Timolol maleateDrug

    Also called Timoptic., Timolol., Timolol maleate.

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

Study groups in NCT01607671
Study groupRoleWhat they receive
TimololExperimentalThis group will receive ophthalmic Timolol maleate 0.5%, 1 drop to the effected eye twice daily for 4 weeks.
Receives: Drug: Timolol maleate
Standard CareNo interventionThis group will be treated with current standard care. This does not include Timolol or other medications to reduce intraocular pressure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. Number of patients with adverse events

    Measured: 12 months

Secondary outcomes (4)

  1. 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.

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

  2. 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.

    Measured: 48 hours after enrollment, 1 month, 3 months

  3. 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.

    Measured: Within 48 hours of enrollment, 1 month, 3 months

  4. 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.

    Measured: 48 hours from enrollment, 1 month, 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionNov 2013
  4. Study completionNov 2013

Why it stopped: Unable to recruit participants from recruiting sites.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01607671
Sponsor's protocol ID
NAION-001
Status last verified
May 2012
First submitted
25 May 2012
Last updated
25 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20006051

  • 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.

    PubMed 8361399

  • 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.

    PubMed 1623958

  • 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.

    PubMed 16151785

  • 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.

    PubMed 7844872

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Timolol maleate in people with Optic Neuropathy, Ischemic and Anterior Ischemic Optic Neuropathy, run by Fraser Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate of patients during the one year study to assess feasibility of a larger study (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01607671, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.

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