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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03422965
• Other study ID #: OCTAMaratoTV3ICOF
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2020
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of the disease.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: May 31, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Retinopathy
• Ischemia
• Retinal Disease
• Retinal Diseases
• Retinal Ischaemia Due to Type 1 Diabetes Mellitus
• Retinal Ischemia
• Retinal Vascular
• Vessels; Retina, Tortuous

Intervention

Diagnostic Test:
• Optical Coherence Tomography Angiography
Optical Coherence Tomography Angiography images capture.
• Blood test
Blood test, systemic markers
• Urine test
Urine test, systemic markers

Locations

Country	Name	City	State
Spain	Diabetes Unit, Institut Clinic de Malalties Digestives i Métaboliques (ICMDM), Hospital Clínic de Barcelona	Barcelona
Spain	Institut Clinic de Oftalmologia (ICOF), Hospital Clínic de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fundació La Marató de TV3

Country where clinical trial is conducted

Spain, 

References & Publications (16)

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. — View Citation

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perifoveal vessel density	OCTA images will be processed to obtain vascular density measurements in this area (mm-1)	24 months
Secondary	Parafoveal vessel density	OCTA images will be processed to obtain vascular density measurements in this area (mm-1)	24 months
Secondary	Total Avascular Area	OCTA images will be processed to obtain total avascular area measurements (mm2)	24 months
Secondary	Foveal Avascular Zone	OCTA images will be processed to obtain foveal avascular zone area measurements (mm2)	24 months