Diabetes MellitusNCT02876393
A Systematic Study of Retinal Structure and Function in Diabetic Macular Oedema
An observational study of Diabetes Mellitus and Diabetic Retinopathy, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
Diabetic retinopathy(DR) is a sight threatening condition that occurs in persons with diabetes. DR arises as a consequence of damage to the retinal blood vessels and is related to the high and fluctuating sugar levels in the blood stream. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
- How many people
- 172 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Jan 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential participants with DR of different severity levels ranging from minimal DR to severe DR with or without DMO who attend the diabetic clinics will be invited to participate. Opportunistic sampling will be used to ensure that the different severity levels of DR and or DMO will be adequately represented.The Northern Ireland Cohort Longitudinal Study On ageing (NICOLA), a non-interventional epidemiological study of healthy ageing in older adults aged 50 years and above has commenced and is currently recruiting some 8500 participants. Participants in NICOLA who are known to have DM or have been recently diagnosed with DM will be approached and asked if willing to return for detailed functional testing of the eye. This will supplement the group with DM but with no changes of DR. Control participants with DM but without DR will be recruited from the metabolic clinics of the Belfast Trust.
Who may be able to join
- Group 1 (Healthy controls without DM):
- Persons older than 18 years without DM
- Fundus free of any signs of retinal disease
- Best Corrected Visual Acuity of 20/40 (73 ETDRS letters) in both eyes
- Group 2 (Persons with DM with no retinopathy):
- Persons with Type 1 or type 2 diabetes older than 18 years
Show all 12Show fewer
- Normal fundus, Absence of features of DR or DMO in both eyes
- Best Corrected Visual Acuity 20/40 (73 ETDRS letters) in at least one eye
- Group 3:
- Persons with Type 1 or type 2 diabetes 18 years and older
- Fundus signs of mild, moderate or severe DR and or DMO
- Best Corrected Visual Acuity 20/200 (33 ETDRS letters) or better
Who cannot join
- Recent ocular surgical procedures performed within the previous 3 months
- Presence of ocular confounding disorders such as neovascular age related macular degeneration, glaucoma or active uveitis
- Serious life threatening conditions that would preclude attendance in the longitudinal part of the study
- Neurological conditions that can impair vision
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NI clinical Research Facility,51 Lisburn Road
Belfast, BT9 7AB
About this study
Diabetic retinopathy(DR) is a sight threatening condition that occurs in persons with diabetes. DR arises as a consequence of damage to the retinal blood vessels and is related to the high and fluctuating sugar levels in the blood stream. An eye with DR will have abnormal appearing retinal blood vessels which become engorged and dilated, leaky and fragile or undergo closure. The net result is a picture of haemorrhage and or ischaemia (lack of blood supply). A particular feature of DR is the accumulation of fluid in the macula which is the central part of the retina and responsible for detailed eye sight. This peculiar form of DR is called Diabetic Macular Oedema (DMO). DMO can occur in isolation without other features of DR. DMO is commoner in type 2 diabetes where insulin resistance and abnormalities of blood fats are found. The investigators wish to study DR and DMO using high resolution retinal imaging and functional tests in normal participants, those participants with diabetes without any overt signs of disease and those with DR and DMO in order to understand how the condition develops and whether there are any unique risk factors that can be identified
- Medical subject headings
- Diabetes Mellitus, 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 |
|---|---|---|
| Cases | Persons with type 1 or type 2 DM with features of DR and or DMO ranging from extremely mild to severe. | |
| Control definition | Persons with a history of type 1 or type 2 DM without any clinical features of DR or DMO in either eye or persons without a history of DM and without retinal disease in either eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of DMO evaluated from the optical coherence tomography (OCT) images
Measured: The outcome measures will be assessed at the end of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startNov 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usha Chakravarthy, Queen's University, Belfast
- Investigators
- Prof Usha Chakravarthy, Phd FRCopth, Principal investigator, Queens University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876393
- Sponsor's protocol ID
- 14/NI/1025
- Status last verified
- Apr 2019
- First submitted
- 28 Apr 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Study of Retinal Structure and Function in Diabetic Macular Oedema
- ClinicalTrials.gov ID
- NCT02876393
- Acronym / sponsor ID
- 14/NI/1025
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 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.
Diabetic retinopathy(DR) is a sight threatening condition that occurs in persons with diabetes. DR arises as a consequence of damage to the retinal blood vessels and is related to the high and fluctuating sugar levels in the blood stream. An eye with DR will have abnormal appearing retinal blood vessels which become engorged and dilated, leaky and fragile or undergo closure. The net result is a picture of haemorrhage and or ischaemia (lack of blood supply). A particular feature of DR is the accumulation of fluid in the macula which is the central part of the retina and responsible for detailed eye sight. This peculiar form of DR is called Diabetic Macular Oedema (DMO). DMO can occur in isolation without other features of DR. DMO is commoner in type 2 diabetes where insulin resistance and abnormalities of blood fats are found. The investigators wish to study DR and DMO using high resolution retinal imaging and functional tests in normal participants, those participants with diabetes without any overt signs of disease and those with DR and DMO in order to understand how the condition develops and whether there are any unique risk factors that can be identified
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Persons with type 1 or type 2 DM with features of DR and or DMO ranging from extremely mild to severe. |
| Control definition | – | –Persons with a history of type 1 or type 2 DM without any clinical features of DR or DMO in either eye or persons without a history of DM and without retinal disease in either eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants with DR of different severity levels ranging from minimal DR to severe DR with or without DMO who attend the diabetic clinics will be invited to participate. Opportunistic sampling will be used to ensure that the different severity levels of DR and or DMO will be adequately represented.The Northern Ireland Cohort Longitudinal Study On ageing (NICOLA), a non-interventional epidemiological study of healthy ageing in older adults aged 50 years and above has commenced and is currently recruiting some 8500 participants. Participants in NICOLA who are known to have DM or have been recently diagnosed with DM will be approached and asked if willing to return for detailed functional testing of the eye. This will supplement the group with DM but with no changes of DR. Control participants with DM but without DR will be recruited from the metabolic clinics of the Belfast Trust.
Key inclusion criteria (12 listed)
- Persons older than 18 years without DM
- Fundus free of any signs of retinal disease
- Best Corrected Visual Acuity of 20/40 (73 ETDRS letters) in both eyes
- Persons with Type 1 or type 2 diabetes older than 18 years
- Normal fundus, Absence of features of DR or DMO in both eyes
Key exclusion criteria (4 listed)
- Recent ocular surgical procedures performed within the previous 3 months
- Presence of ocular confounding disorders such as neovascular age related macular degeneration, glaucoma or active uveitis
- Serious life threatening conditions that would preclude attendance in the longitudinal part of the study
- Neurological conditions that can impair vision
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
Presence of DMO evaluated from the optical coherence tomography (OCT) images
Time frame: The outcome measures will be assessed at the end of 3 months
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 4 Apr 2019.
Related trials for Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
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.
Prof Usha Chakravarthy, Phd FRCopth principal investigator
Queens University Belfast
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 Diabetes Mellitus and Diabetic Retinopathy, run by Queen's University, Belfast 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 12 inclusion and 4 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 4 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?
Presence of DMO evaluated from the optical coherence tomography (OCT) images (time frame: The outcome measures will be assessed at the end of 3 months). 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 4 Apr 2019.