Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration (TORPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00940407
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : November 18, 2011
Information provided by (Responsible Party):
Merry, Graham, M.D.

Brief Summary:

The purpose of this study is to evaluate clinical outcomes of Photobiomodulation treatment on patients with dry Age Related Macular Degeneration (AMD).

Photobiomodulation is the use of non thermal, non laser light of specific wavelengths and energy directly on the eye to improve retinal function and delay AMD progression.

This is a prospective 2 center phase 2 clinical pilot study with no placebo group.

Condition or disease Intervention/treatment Phase
Nonexudative Age-related Macular Degeneration Device: Photobiomodulation (Gentlewaves, Warp 10) Phase 2

Detailed Description:

Dry AMD is a progressive sight threatening disease affecting central acute vision. Dry AMD may progress to the wet form where leaking and bleeding in the retina can cause sudden severe visual loss.

There are no proven active treatments for Dry AMD. Dry AMD accounts for over 80% of AMD cases.

There are estimated to be 30 million people afflicted with AMD by the year 2020 in North America.

Photobiomodulation in this study is utilised by using two devices that are already approved for other indications by the FDA and Health Canada.

Photobiomodulation is a novel clinical application for treating dry AMD. As this is a pilot study there is no placebo or control group.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.
Study Start Date : January 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Photobiomodulation (Gentlewaves, Warp 10)
    Two separate light emitting devices that are already approved for other indications are used. Treatment will consist of 18 treatments lasting approximately two minutes per treatment.
    Other Names:
    • Gentlewaves
    • Warp 10

Primary Outcome Measures :
  1. Change in ETDRS Visual Acuity [ Time Frame: prior to intervention and 3 monthly intervals to 1 year ]

Secondary Outcome Measures :
  1. change in contrast sensitivity [ Time Frame: prior to intervention and 3 monthly to 1 year ]
  2. changes in retinal function parameters from Nidek MP1 assessment [ Time Frame: prior to intervention and 3 monthly to 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients of both genders aged 50 years inclusive and over
  • patients must have DRY macular degeneration in the study eye
  • best corrected visual acuity between 20/40 and 20/200
  • patients must be competent to sign and have signed a consent form before study entry

Exclusion Criteria:

  • visually significant cataracts
  • presence of a visually significant posterior capsule if prior cataract has been performed
  • any visually significant disease process in any ocular structure that would affect vision unrelated to macular degeneration
  • a patient can be enrolled if only one of their eyes meets the criteria
  • patients with severe clinically significant medical disease or unstable medical conditions including cardiovascular, hepatic, renal, neurological, endocrine, gastrointestinal, CNS or life threatening disease or current malignancy at the discretion of the investigators
  • patients who are non-ambulatory or bed ridden
  • female patients who are pregnant or of childbearing potential as the effects of PBM on the developing fetus are unknown
  • patients with a history of epilepsy
  • patients with a history of alcohol, drug or substance abuse in the past 6 months
  • patients deemed uncooperative or non compliant with the requirements of the protocol
  • patients who have received any investigational drug or treatment within 30 days prior to study entry
  • patients who are not competent to understand and sign consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00940407

United States, Tennessee
Dr Robert Dotson
Oak Ridge, Tennessee, United States, 37830
Canada, Ontario
Dr Graham Merry
Toronto, Ontario, Canada, M5R 1C4
Sponsors and Collaborators
Merry, Graham, M.D.
Principal Investigator: Graham F Merry, MBBS; LMCC Dr. Graham Merry
Principal Investigator: Robert Dotson, M.D. Dr. Robert Dotson

Responsible Party: Merry, Graham, M.D. Identifier: NCT00940407     History of Changes
Other Study ID Numbers: TOPRPA 08001
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: November 2011

Keywords provided by Merry, Graham, M.D.:
dry AMD
light treatment
eye disease
ageing eye disease

Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases