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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merry, Graham, M.D.
ClinicalTrials.gov Identifier:
NCT00940407
First received: July 14, 2009
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Nonexudative Age-related Macular Degeneration
 Device: Photobiomodulation (Gentlewaves, Warp 10)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merry, Graham, M.D.:

Primary Outcome Measures:
  • Change in ETDRS Visual Acuity [ Time Frame: prior to intervention and 3 monthly intervals to 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change in contrast sensitivity [ Time Frame: prior to intervention and 3 monthly to 1 year ] [ Designated as safety issue: No ]
  • changes in retinal function parameters from Nidek MP1 assessment [ Time Frame: prior to intervention and 3 monthly to 1 year ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: January 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940407

Locations
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.
Investigators
Principal Investigator: Graham F Merry, MBBS; LMCC Dr. Graham Merry
Principal Investigator: Robert Dotson, M.D. Dr. Robert Dotson
  More Information

No publications provided

Responsible Party: Merry, Graham, M.D.
ClinicalTrials.gov Identifier: NCT00940407     History of Changes
Other Study ID Numbers: TOPRPA 08001
Study First Received: July 14, 2009
Last Updated: November 16, 2011
Health Authority: United States: Institutional Review Board
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 16, 2013