Type 2 Diabetes MellitusC-TracerNCT01607190
Biomarkers of Diabetic Retinopathy Progression
An observational study of Type 2 Diabetes Mellitus and Mild Nonproliferative Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 2 sites in 2 countries.
Trial summary
The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques. Read more about this study
- Who is it for?
- Ages 35 to 100 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Mild Nonproliferative Diabetic Retinopathy
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2012to Dec 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 35 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy
Who may be able to join
- Type 2 diabetes mellitus
- Age over 35 years-old
- Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria)
- Best Corrected Visual Acuity > 20/25 on the ETDRS chart
- Informed Consent
Who cannot join
- Previous laser therapy
- Other retinal vascular disease
- Glaucoma
- Recent intraocular surgery (in the last 6 months)
- Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract)
- HbA1C > 11 % at the Screening
- Subject that has a condition or that is in a situation which may put him/her at significant risk, may confound the study results or may interfere significantly with his/ her participation in the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Portugal1 site
AIBILI- Association for Biomedical Research and Inovation on Light and Image.
Coimbra, 3000-548
About this study
Official title: Biomarkers of Diabetic Retinopathy Progression.
The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.
- Keywords
- type 2 diabetes mellitus, nonproliferative diabetic retinopathy
- Medical subject headings
- Diabetes Mellitus, Type 2
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 |
|---|---|---|
| Patients with diabetic retinopathy. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSME needing treatment either photocoagulation or ITV.
Measured: Months 0, 6, 12 and 24.
Secondary outcomes (4)
Best corrected visual acuity.
Measured: Months 0, 6, 12 and 24.
Vision loss of at least 2 lines documented in ETDRS charts
Measured: Months 0, 6, 12 and 24.
Central retinal thickness
Measured: Months 0, 6, 12 and 24.
Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover)
Measured: Months 0, 6, 12 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Cunha-Vaz, MD, PhD, Study chair, Association for Innovation and Biomedical Research on Light and Image
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607190
- Sponsor's protocol ID
- 4C-2012-02
- Acronym
- C-Tracer
- Status last verified
- Jul 2018
- First submitted
- 23 May 2012
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.
PubMed 28785768
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Diabetic Retinopathy Progression.
- ClinicalTrials.gov ID
- NCT01607190
- Acronym / sponsor ID
- C-Tracer / 4C-2012-02
- Keywords
- type 2 diabetes mellitus, nonproliferative diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 May 2012 (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 validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetic retinopathy. | – | – |
Who may qualify
- Ages
- 35 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus
- Age over 35 years-old
- Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria)
- Best Corrected Visual Acuity > 20/25 on the ETDRS chart
- Informed Consent
Key exclusion criteria (7 listed)
- Previous laser therapy
- Other retinal vascular disease
- Glaucoma
- Recent intraocular surgery (in the last 6 months)
- Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract)
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
CSME needing treatment either photocoagulation or ITV.
Time frame: Months 0, 6, 12 and 24.
4 secondary outcomes
Best corrected visual acuity.
Time frame: Months 0, 6, 12 and 24.
Vision loss of at least 2 lines documented in ETDRS charts
Time frame: Months 0, 6, 12 and 24.
Central retinal thickness
Time frame: Months 0, 6, 12 and 24.
Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover)
Time frame: Months 0, 6, 12 and 24.
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 19 Jul 2018.
- Derived from this study: PubMed 28785768Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.
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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.
José Cunha-Vaz, MD, PhD study chair
Association for Innovation and Biomedical Research on Light and Image
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Mild Nonproliferative Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image 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 5 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 19 Jul 2018. 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 India, Portugal. 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?
CSME needing treatment either photocoagulation or ITV. (time frame: Months 0, 6, 12 and 24.). 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 NCT01607190, which also lists 1 linked publication.
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 19 Jul 2018.