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

Nonexudative Age-related Macular Degeneration Clinical Trial

— TORPA  

Official title:

A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940407
• Other study ID #: TOPRPA 08001
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2009
• Last updated: November 16, 2011
• Start date: January 2009
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Merry, Graham, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geographic Atrophy
• Macular Degeneration
• Nonexudative Age-related Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Canada	Dr Graham Merry	Toronto	Ontario
United States	Dr Robert Dotson	Oak Ridge	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Merry, Graham, M.D.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ETDRS Visual Acuity		prior to intervention and 3 monthly intervals to 1 year
Secondary	change in contrast sensitivity		prior to intervention and 3 monthly to 1 year
Secondary	changes in retinal function parameters from Nidek MP1 assessment		prior to intervention and 3 monthly to 1 year