Primary Open Angle GlaucomaNCT02863224
Advanced Glycation End Products as a Biomarker for Accelerated Ageing
An observational study of Primary Open Angle Glaucoma and Normal Tension Glaucoma, run by University of Plymouth at 1 site in United Kingdom.
Trial summary
Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is advancing age. The rate of ageing is not the same in all age matched individuals. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma, Normal Tension Glaucoma, Ocular Hypertension
- How many people
- 131 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Sep 2018
- 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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls, ocular hypertension, primary open angle glaucoma and normal tension glaucoma groups aged 50 years and older will be studied. Different parameters will be looked at with an aim to understand ageing in glaucomatous optic neuropathy.
Who may be able to join
- Must have had an eye test within the last two years
- Aged 50+
- Informed, written consent
- Have adequate understanding of English language to be able to comprehend the oral and written instructions.
- Participants must be able to complete a 12-hour overnight fast, which includes no alcohol or caffeine.
- Inclusion criteria for Ocular hypertension, Primary open angle glaucoma and normal tension glaucoma:
- Follows guidelines set out within the protocol and used at Derriford REI
Who cannot join
- Diabetes
- Current smokers
- History of stroke/TIA
- Coronary artery disease/heart failure/arrhythmia/angina
- Peripheral vascular disease
- Severe dyslipidaemia
- Hyper/hypothyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Glycation End Products as a Biomarker for Accelerated Ageing in Glaucomatous Optic Neuropathy
Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is advancing age. The rate of ageing is not the same in all age matched individuals. The concept of accelerated ageing suggests that the presence of a number of specific genetic, environmental or systemic risk factors may cumulate to accelerate the ageing process in some individuals and lead to the development of age-related disease. Understanding the factors that influence accelerated ageing is vital.
Advanced glycation end products (AGEs) are a complex group of compounds that are naturally formed. They accumulate gradually with age in cells, tissues and blood vessels throughout the body where they adversely affect structure and function. Circulating AGE levels can be influenced by oxidative stress levels and dietary intake. Recent research has found that sustained exposure to high levels of circulating AGEs could be a major factor in the development of a number of chronic age-related degenerative disorders, including POAG.
Read more
To date there have been few clinical studies that have been able to non-invasively explore the association between AGE levels and the development and progression of glaucomatous optic neuropathy (GON), or to explore the possible contribution that oxidative stress and dietary intake make to total tissue AGE levels in such patients. Furthermore little is understood about the relationship between AGE levels and retinal vascular function, a parameter known to be altered in GON that also could be influenced by AGE levels.
The proposed study will aim to evaluate whether tissue-bound AGE levels are associated with parameters of retinal vascular function, oxidative stress, dietary intake and the presence of GON. Establishing this association could increase our understanding of the pathogenesis of GON and allow a new biomarker for accelerated ocular ageing to be realised
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma, Ocular Hypertension
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 |
|---|---|---|
| Healthy control | Not described | |
| Ocular hypertension | Not described | |
| Primary open angle glaucoma | Not described | |
| Normal tension glaucoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue bound AGE level (AU)
Level of AGE found in the skin - measured from the lower portion of the arm
Measured: Tissue bound AGE level (AU) will be measured for each participant at their second session (within 3 months of volunteering).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leanne Smewing, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863224
- Sponsor's protocol ID
- 204642
- Status last verified
- Apr 2019
- First submitted
- 8 Aug 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Glycation End Products as a Biomarker for Accelerated Ageing in Glaucomatous Optic Neuropathy
- ClinicalTrials.gov ID
- NCT02863224
- Acronym / sponsor ID
- 204642
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 11 Aug 2016 (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.
Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is advancing age. The rate of ageing is not the same in all age matched individuals. The concept of accelerated ageing suggests that the presence of a number of specific genetic, environmental or systemic risk factors may cumulate to accelerate the ageing process in some individuals and lead to the development of age-related disease. Understanding the factors that influence accelerated ageing is vital.
Advanced glycation end products (AGEs) are a complex group of compounds that are naturally formed. They accumulate gradually with age in cells, tissues and blood vessels throughout the body where they adversely affect structure and function. Circulating AGE levels can be influenced by oxidative stress levels and dietary intake. Recent research has found that sustained exposure to high levels of circulating AGEs could be a major factor in the development of a number of chronic age-related degenerative disorders, including POAG.
To date there have been few clinical studies that have been able to non-invasively explore the association between AGE levels and the development and progression of glaucomatous optic neuropathy (GON), or to explore the possible contribution that oxidative stress and dietary intake make to total tissue AGE levels in such patients. Furthermore little is understood about the relationship between AGE levels and retinal vascular function, a parameter known to be altered in GON that also could be influenced by AGE levels.
The proposed study will aim to evaluate whether tissue-bound AGE levels are associated with parameters of retinal vascular function, oxidative stress, dietary intake and the presence of GON. Establishing this association could increase our understanding of the pathogenesis of GON and allow a new biomarker for accelerated ocular ageing to be realised
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | – |
| Ocular hypertension | – | – |
| Primary open angle glaucoma | – | – |
| Normal tension glaucoma | – | – |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls, ocular hypertension, primary open angle glaucoma and normal tension glaucoma groups aged 50 years and older will be studied. Different parameters will be looked at with an aim to understand ageing in glaucomatous optic neuropathy.
Key inclusion criteria (7 listed)
- Must have had an eye test within the last two years
- Aged 50+
- Informed, written consent
- Have adequate understanding of English language to be able to comprehend the oral and written instructions.
- Participants must be able to complete a 12-hour overnight fast, which includes no alcohol or caffeine.
Key exclusion criteria (7 listed)
- Diabetes
- Current smokers
- History of stroke/TIA
- Coronary artery disease/heart failure/arrhythmia/angina
- Peripheral vascular disease
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
Tissue bound AGE level (AU)
Time frame: Tissue bound AGE level (AU) will be measured for each participant at their second session (within 3 months of volunteering).
Level of AGE found in the skin - measured from the lower portion of the arm
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 16 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Primary Open Angle Glaucoma and Normal Tension Glaucoma, run by University of Plymouth at 1 site in United Kingdom.
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 7 inclusion and 7 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 16 Apr 2019. 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 United Kingdom. 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?
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?
Tissue bound AGE level (AU) (time frame: Tissue bound AGE level (AU) will be measured for each participant at their second session (within 3 months of volunteering).). 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 16 Apr 2019.