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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nonexudative Age-related Macular Degeneration

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Gentlewaves Warp 10

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Graham F Merry, MBBS; LMCC

Role: PRINCIPAL_INVESTIGATOR

Dr. Graham Merry

Robert Dotson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dr. Robert Dotson

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr Robert Dotson

Oak Ridge, Tennessee, United States

Site Status

Dr Graham Merry

Toronto, Ontario, Canada