Nonexudative Age-related Macular DegenerationPhase 2TORPANCT00940407
Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration
A Phase 2 study testing Photobiomodulation (Gentlewaves, Warp 10) in people with Nonexudative Age-related Macular Degeneration, run by Merry, Graham, M.D. at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Nonexudative Age-related Macular Degeneration
- What is being tested?
- Photobiomodulation (Gentlewaves, Warp 10)
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2009to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.
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.
- Being tested
- Photobiomodulation (Gentlewaves, Warp 10)
- Keywords
- dry AMD, light treatment, ARMD, photobiomodulation, macular, eye disease, ageing eye disease
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation (Gentlewaves, Warp 10)Device
Also called 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ETDRS Visual Acuity
Measured: prior to intervention and 3 monthly intervals to 1 year
Secondary outcomes (2)
change in contrast sensitivity
Measured: prior to intervention and 3 monthly to 1 year
changes in retinal function parameters from Nidek MP1 assessment
Measured: prior to intervention and 3 monthly to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonexudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merry, Graham, M.D.
- Responsible party
- Sponsor
- Investigators
- Graham F Merry, MBBS; LMCC, Principal investigator, Dr. Graham MerryRobert Dotson, M.D., Principal investigator, Dr. Robert Dotson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940407
- Sponsor's protocol ID
- TOPRPA 08001
- Acronym
- TORPA
- Status last verified
- Nov 2011
- First submitted
- 14 Jul 2009
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.
- ClinicalTrials.gov ID
- NCT00940407
- Acronym / sponsor ID
- TORPA / TOPRPA 08001
- Keywords
- dry AMD, light treatment, ARMD, photobiomodulation, macular, eye disease, ageing eye disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Merry, Graham, M.D.
- Study start
- Jan 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation (Gentlewaves, Warp 10)Also: Gentlewaves, Warp 10Two 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. | Device | – |
Primary outcome
Change in ETDRS Visual Acuity
Time frame: prior to intervention and 3 monthly intervals to 1 year
2 secondary outcomes
change in contrast sensitivity
Time frame: prior to intervention and 3 monthly to 1 year
changes in retinal function parameters from Nidek MP1 assessment
Time frame: prior to intervention and 3 monthly to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.
Related trials for Nonexudative Age-related Macular Degeneration
RecruitingPhase 2
A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Geographic Atrophy of the Macula
Recruiting
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
Age-Related Macular Degeneration, Age-related Macular Degeneration (ARMD)
Active, not recruiting
Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD
Geographic Atrophy
Recruiting
Atrophic Age-related Macular Degeneration Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma
Dry Age-related Macular Degeneration
RecruitingObservational study
Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Age-Related Macular Degeneration, Geographic Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham F Merry, MBBS; LMCC principal investigator
Dr. Graham Merry
Robert Dotson, M.D. principal investigator
Dr. Robert Dotson
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photobiomodulation (Gentlewaves, Warp 10) in people with Nonexudative Age-related Macular Degeneration, run by Merry, Graham, M.D. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ETDRS Visual Acuity (time frame: prior to intervention and 3 monthly intervals to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2011.