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CompletedNCT00940407TORPAUpdated Nov 18, 2011

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

A Phase 2 interventional study of Photobiomodulation (Gentlewaves, Warp 10) in Nonexudative Age-related Macular Degeneration, sponsored by Merry, Graham, M.D.. Completed at 2 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2011-11-18.

Sponsored by Merry, Graham, M.D. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nonexudative Age-related Macular Degeneration

Keywords

  • dry AMD
  • light treatment
  • ARMD
  • photobiomodulation
  • macular
  • eye disease
  • ageing eye disease
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 18 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

This is the only study on the registry with Merry, Graham, M.D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Interventions

  • DevicePhotobiomodulation (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.

    Also known as: Gentlewaves, Warp 10

06

What researchers measure

Primary outcomes

  1. Change in ETDRS Visual Acuity

    Time frame: prior to intervention and 3 monthly intervals to 1 year

Secondary outcomes

  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

07

Study locations

2 sites
  • Dr Robert Dotson
    Oak Ridge, Tennessee 37830, United States
  • Dr Graham Merry
    Toronto, Ontario M5R 1C4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00940407
Lead sponsor
Merry, Graham, M.D.
Responsible party
Sponsor
First posted
Jul 16, 2009
Start date
Jan 2009
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Nov 18, 2011

Study contacts

Graham F Merry, MBBS; LMCC
principal investigator · Dr. Graham Merry
Robert Dotson, M.D.
principal investigator · Dr. Robert Dotson

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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