search
Back to results

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

Primary Purpose

Retinal Vascular, Retinal Disease, Retinal Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Optical Coherence Tomography Angiography
Blood test
Urine test
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Retinal Vascular focused on measuring Retina, OCT, Optical Coherence Tomography, Optical Coherence Tomography Angiography, Systemic, Blood, Diabetes Mellitus, Diabetic Retinopathy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Healthy controls

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Type 1 Diabetes Mellitus

Healthy controls

Arm Description

Cohort of Type 1 DM patients

Cohort of Healthy controls

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parafoveal vessel density
OCTA images will be processed to obtain vascular density measurements in this area (mm-1)
Total Avascular Area
OCTA images will be processed to obtain total avascular area measurements (mm2)
Foveal Avascular Zone
OCTA images will be processed to obtain foveal avascular zone area measurements (mm2)

Full Information

First Posted
January 24, 2018
Last Updated
July 27, 2020
Sponsor
Hospital Clinic of Barcelona
Collaborators
Fundació La Marató de TV3
search

1. Study Identification

Unique Protocol Identification Number
NCT03422965
Brief Title
Perifoveal Vascular Network Assessed by OCT-Angiography in Type I Diabetes Mellitus
Official Title
Evaluation of Microvascular Changes in the Perifoveal Vascular Network Using Optical Coherence Tomography Angiography (OCT-A) in Type I Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
March 8, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Fundació La Marató de TV3

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 of the disease.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vascular, Retinal Disease, Retinal Ischemia, Retinal Ischaemia Due to Type 1 Diabetes Mellitus, Diabetes Mellitus, Diabetic Retinopathy, Diabetes Mellitus, Type 1, Vessels; Retina, Tortuous
Keywords
Retina, OCT, Optical Coherence Tomography, Optical Coherence Tomography Angiography, Systemic, Blood, Diabetes Mellitus, Diabetic Retinopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type 1 Diabetes Mellitus
Arm Type
Active Comparator
Arm Description
Cohort of Type 1 DM patients
Arm Title
Healthy controls
Arm Type
Sham Comparator
Arm Description
Cohort of Healthy controls
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical Coherence Tomography Angiography
Intervention Description
Optical Coherence Tomography Angiography images capture.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood test
Intervention Description
Blood test, systemic markers
Intervention Type
Diagnostic Test
Intervention Name(s)
Urine test
Intervention Description
Urine test, systemic markers
Primary Outcome Measure Information:
Title
Perifoveal vessel density
Description
OCTA images will be processed to obtain vascular density measurements in this area (mm-1)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Parafoveal vessel density
Description
OCTA images will be processed to obtain vascular density measurements in this area (mm-1)
Time Frame
24 months
Title
Total Avascular Area
Description
OCTA images will be processed to obtain total avascular area measurements (mm2)
Time Frame
24 months
Title
Foveal Avascular Zone
Description
OCTA images will be processed to obtain foveal avascular zone area measurements (mm2)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Type 1 Diabetes Mellitus Healthy controls Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Zarranz-Ventura, MD PhD FEBO
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Clinic de Oftalmologia (ICOF), Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Diabetes Unit, Institut Clinic de Malalties Digestives i Métaboliques (ICMDM), Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25541604
Citation
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.
Results Reference
background
PubMed Identifier
6367724
Citation
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.
Results Reference
background
PubMed Identifier
19265246
Citation
Shah CA. Diabetic retinopathy: A comprehensive review. Indian J Med Sci. 2008 Dec;62(12):500-19.
Results Reference
background
PubMed Identifier
26904690
Citation
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.
Results Reference
background
PubMed Identifier
23689796
Citation
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.
Results Reference
background
PubMed Identifier
25759962
Citation
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.
Results Reference
background
PubMed Identifier
5684307
Citation
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.
Results Reference
background
PubMed Identifier
8960844
Citation
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.
Results Reference
background
PubMed Identifier
1891225
Citation
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.
Results Reference
background
PubMed Identifier
19395034
Citation
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.
Results Reference
background
PubMed Identifier
22418228
Citation
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.
Results Reference
background
PubMed Identifier
25897021
Citation
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.
Results Reference
background
PubMed Identifier
25896459
Citation
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.
Results Reference
background
PubMed Identifier
26469537
Citation
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.
Results Reference
background
PubMed Identifier
26457396
Citation
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.
Results Reference
background
PubMed Identifier
26795548
Citation
Hwang TS, Gao SS, Liu L, Lauer AK, Bailey ST, Flaxel CJ, Wilson DJ, Huang D, Jia Y. Automated Quantification of Capillary Nonperfusion Using Optical Coherence Tomography Angiography in Diabetic Retinopathy. JAMA Ophthalmol. 2016 Apr;134(4):367-73. doi: 10.1001/jamaophthalmol.2015.5658.
Results Reference
background
PubMed Identifier
34573883
Citation
Bernal-Morales C, Ale-Chilet A, Martin-Pinardel R, Barraso M, Hernandez T, Oliva C, Vinagre I, Ortega E, Figueras-Roca M, Sala-Puigdollers A, Gimenez M, Esmatjes E, Adan A, Zarranz-Ventura J. Optical Coherence Tomography Angiography in Type 1 Diabetes Mellitus. Report 4: Glycated Haemoglobin. Diagnostics (Basel). 2021 Aug 25;11(9):1537. doi: 10.3390/diagnostics11091537.
Results Reference
derived
PubMed Identifier
33062397
Citation
Barraso M, Ale-Chilet A, Hernandez T, Oliva C, Vinagre I, Ortega E, Figueras-Roca M, Sala-Puigdollers A, Esquinas C, Esmatjes E, Adan A, Zarranz-Ventura J. Optical Coherence Tomography Angiography in Type 1 Diabetes Mellitus. Report 1: Diabetic Retinopathy. Transl Vis Sci Technol. 2020 Sep 30;9(10):34. doi: 10.1167/tvst.9.10.34. eCollection 2020 Sep.
Results Reference
derived
PubMed Identifier
31752726
Citation
Zarranz-Ventura J, Barraso M, Ale-Chilet A, Hernandez T, Oliva C, Gascon J, Sala-Puigdollers A, Figueras-Roca M, Vinagre I, Ortega E, Esmatjes E, Adan A. Evaluation of microvascular changes in the perifoveal vascular network using optical coherence tomography angiography (OCTA) in type I diabetes mellitus: a large scale prospective trial. BMC Med Imaging. 2019 Nov 21;19(1):91. doi: 10.1186/s12880-019-0391-8.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs