search
Back to results

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

Primary Purpose

Nonexudative Age-related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Photobiomodulation (Gentlewaves, Warp 10)
Sponsored by
Merry, Graham, M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonexudative Age-related Macular Degeneration focused on measuring dry AMD, light treatment, ARMD, photobiomodulation, macular, eye disease, ageing eye disease

Eligibility Criteria

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

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

Sites / Locations

  • Dr Robert Dotson
  • Dr Graham Merry

Outcomes

Primary Outcome Measures

Change in ETDRS Visual Acuity

Secondary Outcome Measures

change in contrast sensitivity
changes in retinal function parameters from Nidek MP1 assessment

Full Information

First Posted
July 14, 2009
Last Updated
November 16, 2011
Sponsor
Merry, Graham, M.D.
search

1. Study Identification

Unique Protocol Identification Number
NCT00940407
Brief Title
Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration
Acronym
TORPA
Official Title
A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merry, Graham, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonexudative Age-related Macular Degeneration
Keywords
dry AMD, light treatment, ARMD, photobiomodulation, macular, eye disease, ageing eye disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Photobiomodulation (Gentlewaves, Warp 10)
Other Intervention Name(s)
Gentlewaves, Warp 10
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in ETDRS Visual Acuity
Time Frame
prior to intervention and 3 monthly intervals to 1 year
Secondary Outcome Measure Information:
Title
change in contrast sensitivity
Time Frame
prior to intervention and 3 monthly to 1 year
Title
changes in retinal function parameters from Nidek MP1 assessment
Time Frame
prior to intervention and 3 monthly to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham F Merry, MBBS; LMCC
Organizational Affiliation
Dr. Graham Merry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Dotson, M.D.
Organizational Affiliation
Dr. Robert Dotson
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Robert Dotson
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
Country
United States
Facility Name
Dr Graham Merry
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5R 1C4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs