Clinical trial NCT00940407: Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonexudative Age-related Macular Degeneration
Keywords: dry AMD
light treatment
ARMD
photobiomodulation
macular
eye disease
ageing eye disease
Lead sponsor: Merry, Graham, M.D.
Sponsor class: INDIV
First posted: 2009-07-16
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in ETDRS Visual Acuity
timeFrame: prior to intervention and 3 monthly intervals to 1 year
Secondary outcomes:
measure: change in contrast sensitivity
timeFrame: prior to intervention and 3 monthly to 1 year
measure: changes in retinal function parameters from Nidek MP1 assessment
timeFrame: prior to intervention and 3 monthly to 1 year
Other outcomes:
Locations:
city: Oak Ridge
country: United States
facility: Dr Robert Dotson
state: Tennessee
city: Toronto
country: Canada
facility: Dr Graham Merry
state: Ontario
Study officials:
affiliation: Dr. Graham Merry
name: Graham F Merry, MBBS; LMCC
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Robert Dotson
name: Robert Dotson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: