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Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT

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ClinicalTrials.gov Identifier: NCT03765112
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Eduardo Navajas, University of British Columbia

Brief Summary:
This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Retinopathy Device: Optical coherence tomography angiography Not Applicable

Detailed Description:

The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment due to closure of capillaries. High-resolution imaging techniques of the retina and its supplying vascular networks can allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In this study capillary changes of patients with different severity levels of diabetic retinopathy will be investigated with non-invasive imaging technology to better understand the process of disease progression.

Imaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral domain OCT and ultra wide-field imaging.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OCTA
Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging.
Device: Optical coherence tomography angiography
Multiple scans of the retina will be recorded to evaluate microvascular changes.




Primary Outcome Measures :
  1. Perfusion density [ Time Frame: 6 months ]
    The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.


Secondary Outcome Measures :
  1. Areas of different perfusion density [ Time Frame: 6 months ]
    Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient

  2. Foveal avascular zone (FAZ) [ Time Frame: 6 months ]
    Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.

  3. Foveal avascular zone (FAZ) [ Time Frame: 6 months ]
    The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.

  4. Presence of predominantly peripheral lesions (PPL) [ Time Frame: 6 months ]
    The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA

  5. Retinal layer thickness [ Time Frame: 6 months ]
    Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA

  6. Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year [ Time Frame: 18 months ]
    Patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR will be followed over one year. Perfusion density will be measured at each timepoint and followed over the year,



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥18 Participants can have 1 or 2 study eyes

Patient Group:

  • Diabetes mellitus type 1 or 2
  • Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR

Exclusion Criteria:

  • Substantial media opacities that would preclude successful imaging

    • Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye
    • Structural damage to the center of macula in the study eye
    • History of prior panretinal photocoagulation
    • History of treatment with intravitreal agents over the prior 6 months
    • Macular edema involving the central subfield
    • Prior history of vitrectomy
    • Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
    • Substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies
    • Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye
    • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti‐glaucoma medication)or history of glaucoma filtration surgery
    • Inability to obtain fundus images of sufficient quality to be analyzed and graded

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): NCT03765112


Contacts
Contact: Eduardo Navajas, MD 604 875 5475 edunavajas@gmail.com
Contact: Theresa Wiens 604-875-4111 ext 62544 twiens@eyecarecentre.org

Locations
Canada
Eye Care Center Recruiting
Vancouver, Canada, V5Z 3N9
Contact: Eduardo Navajas, MD    604 875 5475    edunavajas@gmail.com   
Contact: Theresa Wiens, MSc    604-875-4111 ext 62544    twiens@eyecarecentre.org   
Sub-Investigator: Sonja Karst, MD         
Sponsors and Collaborators
University of British Columbia

Responsible Party: Eduardo Navajas, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03765112     History of Changes
Other Study ID Numbers: H18-02095
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Diabetes Mellitus
Retinal Diseases
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications