Age Related Macular DegenerationNCT01348672
Prospective Study Phase: Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye
An observational study of Age Related Macular Degeneration and Glaucoma, run by University of Toronto at 1 site in Canada.
Trial summary
Canadians fear loss of vision more than any other disability. Vision loss has an enormous impact on quality-of-life and is extremely costly from a societal and economic perspective. In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting for 17% of total disability in Canada. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration, Glaucoma, Diabetic Retinopathy.
- How many people
- 381 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Aug 2015
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The cohorts will be selected from the clinics of retinal and glaucoma specialists at the Toronto Western Hospital and will be identified from their charts. Clinicians will ask eligible patients whether they would be interested in participating. Also flyers advertising the study will be posted at Toronto Western Hospital and anyone interested can contact the principal investigator.
Who may be able to join
- Subjects diagnosed with age related macular degeneration
- Subjects diagnosed with glaucoma
- Subjects diagnosed with diabetic retinopathy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Chris Hudson, Ph.D, 416 603 5694, chudson@uwaterloo.ca
About this study
Canadians fear loss of vision more than any other disability. Vision loss has an enormous impact on quality-of-life and is extremely costly from a societal and economic perspective. In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by 65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial cost of vision loss in Canada is $15.8 billion per year. There is a general perception that vision loss is "normal with aging" but 75% of vision loss is estimated to be preventable. The major causes of severe vision loss are age-related macular degeneration (ARMD), glaucoma, particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR). Canada is headed for an epidemic of age-related eye disease and, unless something is done to prepare for this, severe vision loss will have significant consequences in terms of societal and economic costs. Through this proposed Research Program, and in conjunction with the investigators international academic and private sector partners, the investigators will build and develop unique quantitative imaging technologies to permit non-invasive assessment of visual changes, structural changes in the thickness of the retina at the back of the eye and also changes in the amount of blood flowing through the blood vessels that feed the retina with oxygen. This research will add to the investigators basic knowledge in predicting the development of sight-threatening change in patients with the three diseases, and facilitate earlier detection of the problem to help us discover earlier treatments for people with these conditions. The reliability of each imaging technology will be assessed by determining its ability to differentiate between diseased and healthy eyes. Cross-sectional analyses at yearly intervals, as well as change over time analyses, will be undertaken.
Read the detailed description
This research will add to our basic knowledge in predicting the development of sight-threatening change in patient with the ARMD, diabetic retinopathy and primary open glaucoma, and facilitate earlier detection of the problem to help us discover earlier treatments for people with these conditions. The reliability of each imaging technology will be assessed by determining its ability to differentiate between diseased and healthy eyes. Through this proposed Research Program, and in conjunction with our international academic and private sector partners, we will build and develop unique quantitative imaging technologies to:
- Comprehensively assess the blood supply to, and vascular regulation characteristics of the posterior segment of the eye, a diagnostic capability that is currently severely limited.
- Assess oxygen saturation disturbances in the retina and ON that occur prior to clinically detectable changes, diagnostic capability that currently does not exist
- Using the retinal blood supply and oxygen saturation parameters, we will derive net oxygen delivery to the retina and optic nerve head (ONH), a diagnostic capability that does not exist.
- Keywords
- Age related macular degeneration, Glaucoma, Diabetic retinopathy, Retinal oxygen saturation, Blood flow, Vascular function, High resolution imaging
- Medical subject headings
- Macular Degeneration, Glaucoma, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. ARMD Study arm | The ARMD study arm (n=150) consists of 3 groups. The groups are organised according to established risk criteria for clinical progression (AREDS, 2003). Group 1A (n=50); Early stage ARMD with low risk of progression; several small drusen, or a few medium-sized drusen, in one or both eyes. One eye will be randomly selected for the study. Group 2A (n=50); Intermediate ARMD with high risk of progression to advanced ARMD; many medium-sized drusen, or one or more large drusen, in one or both eyes. More severely affected eyewill be selected for the study. Group 3A (n=50); In one eye only, either a break-down of light-sensitive cells and supporting tissue in the central retinal area (i.e. geographic atrophy), or abnormal and fragile blood vessels under the retina (i.e. choroidal neovascular membrane formation). The fellow eye is at high risk of progression to advanced ARMD. The fellow eye will be selected for the study. | |
| 2. POAG study arm | Patient groups are organised according to established risk criteria for clinical progression (EMGT, 2003). Group 1P (n=36); Stable, early to moderate, treated patients with POAG. Early to moderate POAG is defined as having an untreated IOP prior to treatment of >21mmHg and a repeatable visual field defect with a Mean Deviation of <12dB and/or documented but stable ONH appearance, consistent with a diagnosis of glaucoma. Group 2P (n=36); Early to moderate, treated patients with normal tension glaucoma (NTG). Normal Tension Glaucoma is defined using the same criteria as POAG but with an untreated IOP of <21mmHg throughout the day. This group has NTG and is thought to be at increased risk of vascular dysfunction due to loss of ONH perfusion. Group 3P (n=36); Early to moderate, treated patients with POAG or NTG with recurrent disc hemorrhage (indicative of progression). | |
| 3. DR study arm | DR patient groups are organised according to established risk factors for the clinical progression of DR (increasing from Groups 1 A to 3 A, ETDRS, 1991). We will recruit 41 patients per group (Klein et al, 1984). Group 1D (n=41); Type 2 diabetic patients with no, or minimal, clinically visible DR. These patients are at low risk of developing sight-threatening DR. Group 2D (n=41); Type 2 diabetic patients with microaneurysms and / or hard exudates within 2 disc diameters of the fovea and no clinical evidence of retinal thickening. These patients are at increased risk of developing DME. Group 3D (n=41); Type 2 diabetic patients with the typical features of moderate-to-severe DR i.e. venous beading, intra-retinal microvascular abnormalities (IRMA) and dark blot intra-retinal haemorrhages. These patients are at a much increased risk of developing proliferative DR and/or ischemic maculopathy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional relationship between retinal / ON oxygen saturation, vascular dysregulation and retinal morphometry
To investigate the cross-sectional relationship between retinal / ON oxygen saturation, vascular dysregulation and retinal morphometry in groups of patients at risk of progres
Measured: 5 years
Prospective relationship between retinal/ON oxygen saturation disturbances, vascular dysregulation, retinal morphometry and clinical outcomes
To establish the prospective relationship between retinal/ON oxygen saturation disturbances, vascular dysregulation, retinal morphometry and clinical outcomes in patients at risk of progression of ARMD, POAG and DR and age-matched healthy controls
Measured: 5 years
Topographic distribution of retinal / ON oxygen saturation disturbance, vascular dysfunction and change in morphometric parameters
To investigate the topographic distribution of retinal / ON oxygen saturation disturbance, vascular dysfunction and change in morphometric parameters in groups of patients at risk of progression of ARMD, POAG and DR
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMar 2012
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 381 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Research Fund
- Responsible party
- Principal investigator, Chris Hudson, University of Toronto
- Investigators
- Christopher Hudson, OD, PhD, Principal investigator, Toronto Western Hospital, Toronto Western Research Institute, University of Toronto, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348672
- Sponsor's protocol ID
- ORF2
- Status last verified
- Jan 2013
- First submitted
- 27 Feb 2011
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bressler NM, Bressler SB, Congdon NG, Ferris FL 3rd, Friedman DS, Klein R, Lindblad AS, Milton RC, Seddon JM; Age-Related Eye Disease Study Research Group. Potential public health impact of Age-Related Eye Disease Study results: AREDS report no. 11. Arch Ophthalmol. 2003 Nov;121(11):1621-4. doi: 10.1001/archopht.121.11.1621.
PubMed 14609922Klein R, Wang Q, Klein BE, Moss SE, Meuer SM. The relationship of age-related maculopathy, cataract, and glaucoma to visual acuity. Invest Ophthalmol Vis Sci. 1995 Jan;36(1):182-91.
PubMed 7822146Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):823-33.
PubMed 2062515Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984 Apr;102(4):527-32. doi: 10.1001/archopht.1984.01040030405011.
PubMed 6367725Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E; Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003 Jan;121(1):48-56. doi: 10.1001/archopht.121.1.48.
PubMed 12523884
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Phase: Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye
- ClinicalTrials.gov ID
- NCT01348672
- Acronym / sponsor ID
- ORF2
- Keywords
- Age related macular degeneration, Glaucoma, Diabetic retinopathy, Retinal oxygen saturation, Blood flow, Vascular function, High resolution imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 381 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ontario Research Fund
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 5 May 2011 (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.
Canadians fear loss of vision more than any other disability. Vision loss has an enormous impact on quality-of-life and is extremely costly from a societal and economic perspective. In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by 65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial cost of vision loss in Canada is $15.8 billion per year. There is a general perception that vision loss is "normal with aging" but 75% of vision loss is estimated to be preventable. The major causes of severe vision loss are age-related macular degeneration (ARMD), glaucoma, particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR). Canada is headed for an epidemic of age-related eye disease and, unless something is done to prepare for this, severe vision loss will have significant consequences in terms of societal and economic costs. Through this proposed Research Program, and in conjunction with the investigators international academic and private sector partners, the investigators will build and develop unique quantitative imaging technologies to permit non-invasive assessment of visual changes, structural changes in the thickness of the retina at the back of the eye and also changes in the amount of blood flowing through the blood vessels that feed the retina with oxygen. This research will add to the investigators basic knowledge in predicting the development of sight-threatening change in patients with the three diseases, and facilitate earlier detection of the problem to help us discover earlier treatments for people with these conditions. The reliability of each imaging technology will be assessed by determining its ability to differentiate between diseased and healthy eyes. Cross-sectional analyses at yearly intervals, as well as change over time analyses, will be undertaken.
Detailed description
This research will add to our basic knowledge in predicting the development of sight-threatening change in patient with the ARMD, diabetic retinopathy and primary open glaucoma, and facilitate earlier detection of the problem to help us discover earlier treatments for people with these conditions. The reliability of each imaging technology will be assessed by determining its ability to differentiate between diseased and healthy eyes. Through this proposed Research Program, and in conjunction with our international academic and private sector partners, we will build and develop unique quantitative imaging technologies to:
- Comprehensively assess the blood supply to, and vascular regulation characteristics of the posterior segment of the eye, a diagnostic capability that is currently severely limited.
- Assess oxygen saturation disturbances in the retina and ON that occur prior to clinically detectable changes, diagnostic capability that currently does not exist
- Using the retinal blood supply and oxygen saturation parameters, we will derive net oxygen delivery to the retina and optic nerve head (ONH), a diagnostic capability that does not exist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. ARMD Study arm | – | –The ARMD study arm (n=150) consists of 3 groups. The groups are organised according to established risk criteria for clinical progression (AREDS, 2003). Group 1A (n=50); Early stage ARMD with low risk of progression; several small drusen, or a few medium-sized drusen, in one or both eyes. One eye will be randomly selected for the study. Group 2A (n=50); Intermediate ARMD with high risk of progression to advanced ARMD; many medium-sized drusen, or one or more large drusen, in one or both eyes. More severely affected eyewill be selected for the study. Group 3A (n=50); In one eye only, either a break-down of light-sensitive cells and supporting tissue in the central retinal area (i.e. geographic atrophy), or abnormal and fragile blood vessels under the retina (i.e. choroidal neovascular membrane formation). The fellow eye is at high risk of progression to advanced ARMD. The fellow eye will be selected for the study. |
| 2. POAG study arm | – | –Patient groups are organised according to established risk criteria for clinical progression (EMGT, 2003). Group 1P (n=36); Stable, early to moderate, treated patients with POAG. Early to moderate POAG is defined as having an untreated IOP prior to treatment of >21mmHg and a repeatable visual field defect with a Mean Deviation of <12dB and/or documented but stable ONH appearance, consistent with a diagnosis of glaucoma. Group 2P (n=36); Early to moderate, treated patients with normal tension glaucoma (NTG). Normal Tension Glaucoma is defined using the same criteria as POAG but with an untreated IOP of <21mmHg throughout the day. This group has NTG and is thought to be at increased risk of vascular dysfunction due to loss of ONH perfusion. Group 3P (n=36); Early to moderate, treated patients with POAG or NTG with recurrent disc hemorrhage (indicative of progression). |
| 3. DR study arm | – | –DR patient groups are organised according to established risk factors for the clinical progression of DR (increasing from Groups 1 A to 3 A, ETDRS, 1991). We will recruit 41 patients per group (Klein et al, 1984). Group 1D (n=41); Type 2 diabetic patients with no, or minimal, clinically visible DR. These patients are at low risk of developing sight-threatening DR. Group 2D (n=41); Type 2 diabetic patients with microaneurysms and / or hard exudates within 2 disc diameters of the fovea and no clinical evidence of retinal thickening. These patients are at increased risk of developing DME. Group 3D (n=41); Type 2 diabetic patients with the typical features of moderate-to-severe DR i.e. venous beading, intra-retinal microvascular abnormalities (IRMA) and dark blot intra-retinal haemorrhages. These patients are at a much increased risk of developing proliferative DR and/or ischemic maculopathy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohorts will be selected from the clinics of retinal and glaucoma specialists at the Toronto Western Hospital and will be identified from their charts. Clinicians will ask eligible patients whether they would be interested in participating. Also flyers advertising the study will be posted at Toronto Western Hospital and anyone interested can contact the principal investigator.
Key inclusion criteria (3 listed)
- Subjects diagnosed with age related macular degeneration
- Subjects diagnosed with glaucoma
- Subjects diagnosed with diabetic retinopathy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cross-sectional relationship between retinal / ON oxygen saturation, vascular dysregulation and retinal morphometry
Time frame: 5 years
To investigate the cross-sectional relationship between retinal / ON oxygen saturation, vascular dysregulation and retinal morphometry in groups of patients at risk of progres
Prospective relationship between retinal/ON oxygen saturation disturbances, vascular dysregulation, retinal morphometry and clinical outcomes
Time frame: 5 years
To establish the prospective relationship between retinal/ON oxygen saturation disturbances, vascular dysregulation, retinal morphometry and clinical outcomes in patients at risk of progression of ARMD, POAG and DR and age-matched healthy controls
Topographic distribution of retinal / ON oxygen saturation disturbance, vascular dysfunction and change in morphometric parameters
Time frame: 5 years
To investigate the topographic distribution of retinal / ON oxygen saturation disturbance, vascular dysfunction and change in morphometric parameters in groups of patients at risk of progression of ARMD, POAG and DR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
- Background: PubMed 14609922Bressler NM, Bressler SB, Congdon NG, Ferris FL 3rd, Friedman DS, Klein R, Lindblad AS, Milton RC, Seddon JM; Age-Related Eye Disease Study Research Group. Potential public health impact of Age-Related Eye Disease Study results: AREDS report no. 11. Arch Ophthalmol. 2003 Nov;121(11):1621-4. doi: 10.1001/archopht.121.11.1621.
- Background: PubMed 7822146Klein R, Wang Q, Klein BE, Moss SE, Meuer SM. The relationship of age-related maculopathy, cataract, and glaucoma to visual acuity. Invest Ophthalmol Vis Sci. 1995 Jan;36(1):182-91.
- Background: PubMed 2062515Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):823-33.
- Background: PubMed 6367725Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984 Apr;102(4):527-32. doi: 10.1001/archopht.1984.01040030405011.
- Background: PubMed 12523884Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E; Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003 Jan;121(1):48-56. doi: 10.1001/archopht.121.1.48.
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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.
Christopher Hudson, OD, PhD principal investigator
Toronto Western Hospital, Toronto Western Research Institute, University of Toronto, University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration and Glaucoma, run by University of Toronto at 1 site in Canada.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Hudson, Ph.D (416 603 5694, chudson@uwaterloo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional relationship between retinal / ON oxygen saturation, vascular dysregulation and retinal morphometry (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348672, which also lists 5 linked publications.
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 17 Jan 2013.