ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03422965
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Fundació La Marató de TV3
Information provided by (Responsible Party):
Javier Zarranz-Ventura, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
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 Diagnostic Test: Optical Coherence Tomography Angiography Diagnostic Test: Blood test Diagnostic Test: Urine test Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Microvascular Changes in the Perifoveal Vascular Network Using Optical Coherence Tomography Angiography (OCT-A) in Type I Diabetes Mellitus
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : May 8, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Type 1 Diabetes Mellitus
Cohort of Type 1 DM patients
Diagnostic Test: Optical Coherence Tomography Angiography
Optical Coherence Tomography Angiography images capture.

Diagnostic Test: Blood test
Blood test, systemic markers

Diagnostic Test: Urine test
Urine test, systemic markers

Sham Comparator: Healthy controls
Cohort of Healthy controls
Diagnostic Test: Optical Coherence Tomography Angiography
Optical Coherence Tomography Angiography images capture.

Diagnostic Test: Blood test
Blood test, systemic markers

Diagnostic Test: Urine test
Urine test, systemic markers




Primary Outcome Measures :
  1. Perifoveal vessel density [ Time Frame: 24 months ]
    OCTA images will be processed to obtain vascular density measurements in this area (mm-1)


Secondary Outcome Measures :
  1. Parafoveal vessel density [ Time Frame: 24 months ]
    OCTA images will be processed to obtain vascular density measurements in this area (mm-1)

  2. Total Avascular Area [ Time Frame: 24 months ]
    OCTA images will be processed to obtain total avascular area measurements (mm2)

  3. Foveal Avascular Zone [ Time Frame: 24 months ]
    OCTA images will be processed to obtain foveal avascular zone area measurements (mm2)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422965


Contacts
Contact: Javier Zarranz-Ventura, MD PhD FEBO +34932275400 ext 5667 zarranz@clinic.cat

Locations
Spain
Institut Clinic de Oftalmologia (ICOF), Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08028
Contact: Javier Zarranz-Ventura, MD PhD FEBO    +342275400 ext 5667    zarranz@clinic.cat   
Principal Investigator: Javier Zarranz-Ventura, MD PhD FEBO         
Sub-Investigator: Anibal Alé-Chilet, MD         
Sub-Investigator: Marina Barraso-Rodrigo, MD         
Sub-Investigator: Teresa Hernandez, OD         
Sub-Investigator: Cristian Oliva-Parra, OD         
Sub-Investigator: Jesus Gascón, OD         
Sub-Investigator: Anna Sala-Puigdollers, MD         
Sub-Investigator: Marc Figueras-Roca, MD         
Sub-Investigator: Alfredo Adan, MD PhD         
Diabetes Unit, Institut Clinic de Malalties Digestives i Métaboliques (ICMDM), Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Emilio Ortega, MD PhD    +34932275400 ext 3029    eortega1@clinic.cat   
Sub-Investigator: Emilio Ortega, MD PhD         
Sub-Investigator: Irene Vinagre, MD PhD         
Sub-Investigator: Enric Esmatjes, MD PhD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fundació La Marató de TV3
Investigators
Principal Investigator: Javier Zarranz-Ventura, MD PhD FEBO Hospital Clínic de Barcelona

Publications:

Responsible Party: Javier Zarranz-Ventura, MD, PhD, FEBO, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03422965     History of Changes
Other Study ID Numbers: OCTAMaratoTV3ICOF
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier Zarranz-Ventura, Hospital Clinic of Barcelona:
Retina
OCT
Optical Coherence Tomography
Optical Coherence Tomography Angiography
Systemic
Blood
Diabetes Mellitus
Diabetic Retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Diabetic Angiopathies
Diabetes Mellitus
Diabetes Mellitus, Type 1
Ischemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications