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Retinal VascularNCT03422965

Perifoveal Vascular Network Assessed by OCT-Angiography in Type I Diabetes Mellitus

A study testing Optical Coherence Tomography Angiography, Blood test and Urine test in people with Retinal Vascular and Retinal Disease, run by Hospital Clinic of Barcelona at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is directed to evaluate the role of Optical Coherence Tomography Angiography (OCT-A) in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between OCT-A-derived parameters and demographic and clinical factors, as metabolic control and duration… Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
What is being tested?
Optical Coherence Tomography Angiography, Blood test and Urine test
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
2 sitesSpain
Study dates
8 May 2017to 31 May 2021
Phase
Interventional
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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Type 1 Diabetes Mellitus
  • Healthy controls

Who cannot join

  • Ocular pathologies other than diabetic retinopathy (i.e. age-related macular degeneration, retinal vein occlusions, uveitis, glaucoma, etc.)
  • Axial length: <-6.00 to >+3.00 diopters
  • Media Opacities
  • Unability to capture OCT images

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Institut Clinic de Oftalmologia (ICOF), Hospital Clínic de Barcelona

    Barcelona, 08028

  • Diabetes Unit, Institut Clinic de Malalties Digestives i Métaboliques (ICMDM), Hospital Clínic de Barcelona

    Barcelona, 08036

Other trials in Spain

About this study

Official title: Evaluation of Microvascular Changes in the Perifoveal Vascular Network Using Optical Coherence Tomography Angiography (OCT-A) in Type I Diabetes Mellitus

This study is directed to evaluate the role of Optical Coherence Tomography Angiography (OCT-A) in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between OCT-A-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.

Read the detailed description

Diabetic retinopathy (DR) is the leading cause of blindness in type 1 Diabetes Mellitus (DM) patients, as a consequence of impaired blood flow in the retina. Optical coherence tomography angiography (OCT-A) is a newly developed, non-invasive, retinal imaging technique that allows detection of perfused and non perfused areas of the retina without the injection of dye. This OCT-based method permits adequate delineation of the perifoveal vascular network, and allows objective identification of microvascular changes, such as capillary dilation or presence of microaneurisms. It is also capable to detect paramacular areas of capillary non perfusion and/or enlargement of the foveal avascular zone (FAZ), representing an excellent tool for assessment of diabetic retinopathy.

Given that all these features are commonly seen in diabetic patients, the relationship of these microvascular changes with systemic factors such as metabolic control or duration of the disease still need to be elucidated. Interestingly, further studies are required to investigate whether these changes reflect those occurring elsewhere in the body affected by diabetic microvascular disease, as the kidneys or the brain. If these relationships were demonstrated, early detection of these microvascular changes could lead to modifications in the pharmacological management of diabetic patients, as a way to reduce the risk of future complications in both the eye and other organs. The aim of this study is to evaluate the role of OCT-A in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between these OCT-A-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.

Being tested
Optical Coherence Tomography Angiography, Blood test, Urine test
Keywords
Retina, OCT, Optical Coherence Tomography, Optical Coherence Tomography Angiography, Systemic, Blood, Diabetes Mellitus, Diabetic Retinopathy
Medical subject headings
Retinal Diseases, Diabetes Mellitus, Diabetic Retinopathy, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optical Coherence Tomography AngiographyDiagnostic test

    Optical Coherence Tomography Angiography images capture.

  • Blood testDiagnostic test

    Blood test, systemic markers

  • Urine testDiagnostic test

    Urine test, systemic markers

Study groups in NCT03422965
Study groupRoleWhat they receive
Type 1 Diabetes MellitusActive comparatorCohort of Type 1 DM patients
Receives: Diagnostic Test: Optical Coherence Tomography Angiography; Diagnostic Test: Blood test; Diagnostic Test: Urine test
Healthy controlsSham comparatorCohort of Healthy controls
Receives: Diagnostic Test: Optical Coherence Tomography Angiography; Diagnostic Test: Blood test; Diagnostic Test: Urine test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perifoveal vessel density

    OCTA images will be processed to obtain vascular density measurements in this area (mm-1)

    Measured: 24 months

Secondary outcomes (3)

  1. Parafoveal vessel density

    OCTA images will be processed to obtain vascular density measurements in this area (mm-1)

    Measured: 24 months

  2. Total Avascular Area

    OCTA images will be processed to obtain total avascular area measurements (mm2)

    Measured: 24 months

  3. Foveal Avascular Zone

    OCTA images will be processed to obtain foveal avascular zone area measurements (mm2)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2018
  2. Study start8 May 2017
  3. Primary completion8 Mar 2021 (estimated)
  4. Study completion31 May 2021 (estimated)

Resources

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 N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03422965
Sponsor's protocol ID
OCTAMaratoTV3ICOF
Status last verified
Jul 2020
First submitted
24 Jan 2018
Last updated
29 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Song SJ, Wong TY. Current concepts in diabetic retinopathy. Diabetes Metab J. 2014 Dec;38(6):416-25. doi: 10.4093/dmj.2014.38.6.416.

    PubMed 25541604

  • Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol. 1984 Apr;102(4):520-6. doi: 10.1001/archopht.1984.01040030398010.

    PubMed 6367724

  • Shah CA. Diabetic retinopathy: A comprehensive review. Indian J Med Sci. 2008 Dec;62(12):500-19.

    PubMed 19265246

  • Roser P, Kalscheuer H, Groener JB, Lehnhoff D, Klein R, Auffarth GU, Nawroth PP, Schuett F, Rudofsky G. Diabetic Retinopathy Screening Ratio Is Improved When Using a Digital, Nonmydriatic Fundus Camera Onsite in a Diabetes Outpatient Clinic. J Diabetes Res. 2016;2016:4101890. doi: 10.1155/2016/4101890. Epub 2016 Jan 21.

    PubMed 26904690

  • Looker HC, Nyangoma SO, Cromie DT, Olson JA, Leese GP, Philip S, Black MW, Doig J, Lee N, Briggs A, Hothersall EJ, Morris AD, Lindsay RS, McKnight JA, Pearson DW, Sattar NA, Wild SH, McKeigue P, Colhoun HM; Scottish Diabetes Research Network (SDRN) Epidemiology Group and the Scottish Diabetic Retinopathy Collaborative. Predicted impact of extending the screening interval for diabetic retinopathy: the Scottish Diabetic Retinopathy Screening programme. Diabetologia. 2013 Aug;56(8):1716-25. doi: 10.1007/s00125-013-2928-7. Epub 2013 May 21.

    PubMed 23689796

  • Zimmer-Galler IE, Kimura AE, Gupta S. Diabetic retinopathy screening and the use of telemedicine. Curr Opin Ophthalmol. 2015 May;26(3):167-72. doi: 10.1097/ICU.0000000000000142.

    PubMed 25759962

  • Gass JD. A fluorescein angiographic study of macular dysfunction secondary to retinal vascular disease. IV. Diabetic retinal angiopathy. Arch Ophthalmol. 1968 Nov;80(5):583-91. doi: 10.1001/archopht.1968.00980050585004. No abstract available.

    PubMed 5684307

  • Fioretto P, Mauer M, Brocco E, Velussi M, Frigato F, Muollo B, Sambataro M, Abaterusso C, Baggio B, Crepaldi G, Nosadini R. Patterns of renal injury in NIDDM patients with microalbuminuria. Diabetologia. 1996 Dec;39(12):1569-76. doi: 10.1007/s001250050616.

    PubMed 8960844

  • Kwiterovich KA, Maguire MG, Murphy RP, Schachat AP, Bressler NM, Bressler SB, Fine SL. Frequency of adverse systemic reactions after fluorescein angiography. Results of a prospective study. Ophthalmology. 1991 Jul;98(7):1139-42. doi: 10.1016/s0161-6420(91)32165-1.

    PubMed 1891225

  • Yeung L, Lima VC, Garcia P, Landa G, Rosen RB. Correlation between spectral domain optical coherence tomography findings and fluorescein angiography patterns in diabetic macular edema. Ophthalmology. 2009 Jun;116(6):1158-67. doi: 10.1016/j.ophtha.2008.12.063. Epub 2009 Apr 23.

    PubMed 19395034

  • Jia Y, Tan O, Tokayer J, Potsaid B, Wang Y, Liu JJ, Kraus MF, Subhash H, Fujimoto JG, Hornegger J, Huang D. Split-spectrum amplitude-decorrelation angiography with optical coherence tomography. Opt Express. 2012 Feb 13;20(4):4710-25. doi: 10.1364/OE.20.004710.

    PubMed 22418228

  • Jia Y, Bailey ST, Hwang TS, McClintic SM, Gao SS, Pennesi ME, Flaxel CJ, Lauer AK, Wilson DJ, Hornegger J, Fujimoto JG, Huang D. Quantitative optical coherence tomography angiography of vascular abnormalities in the living human eye. Proc Natl Acad Sci U S A. 2015 May 5;112(18):E2395-402. doi: 10.1073/pnas.1500185112. Epub 2015 Apr 20.

    PubMed 25897021

  • Ishibazawa A, Nagaoka T, Takahashi A, Omae T, Tani T, Sogawa K, Yokota H, Yoshida A. Optical Coherence Tomography Angiography in Diabetic Retinopathy: A Prospective Pilot Study. Am J Ophthalmol. 2015 Jul;160(1):35-44.e1. doi: 10.1016/j.ajo.2015.04.021. Epub 2015 Apr 18.

    PubMed 25896459

  • de Carlo TE, Chin AT, Bonini Filho MA, Adhi M, Branchini L, Salz DA, Baumal CR, Crawford C, Reichel E, Witkin AJ, Duker JS, Waheed NK. DETECTION OF MICROVASCULAR CHANGES IN EYES OF PATIENTS WITH DIABETES BUT NOT CLINICAL DIABETIC RETINOPATHY USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2364-70. doi: 10.1097/IAE.0000000000000882.

    PubMed 26469537

  • Takase N, Nozaki M, Kato A, Ozeki H, Yoshida M, Ogura Y. ENLARGEMENT OF FOVEAL AVASCULAR ZONE IN DIABETIC EYES EVALUATED BY EN FACE OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2377-83. doi: 10.1097/IAE.0000000000000849.

    PubMed 26457396

Questions about this trial

What is this clinical trial studying?

A study testing Optical Coherence Tomography Angiography, Blood test and Urine test in people with Retinal Vascular and Retinal Disease, run by Hospital Clinic of Barcelona at 2 sites in Spain.

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 2 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. 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 Spain. 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. Some participants in this study may receive a placebo. 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?

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?

Perifoveal vessel density (time frame: 24 months). 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 NCT03422965, which also lists 23 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 29 Jul 2020.

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