Effect of SGLT2 Inhibition on OCT-A Parameters in Diabetic CKD
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ClinicalTrials.gov Identifier: NCT04215445 |
Recruitment Status :
Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Retinopathy Chronic Kidney Diseases Diabetes Mellitus | Drug: Empagliflozin 25 MG Device: OCT-A | Phase 4 |
This is a prospective, single-centred, open-labeled, randomized clinical trial conducted in ,University Kebangsaan Malaysia Medical Centre (UKMMC). This is also a Quasi-experimental study and all patients from Endocrine, Nephrology and Ophthalmology Clinic in UKM Medical Centre from November 2019 till November 2021 will be involved in this study. Patients who fulfill the inclusion criteria will be included in this study. All eligible subjects will be asked to sign an informed consent.
Participants will be randomized into two groups, diabetic patient with proteinuria and diabetic patient without proteinuria. Participants will be interviewed on demographic data (age, gender, race, blood pressure, Body Mass Index) will be taken. Urine sample and peripheral blood (2-3ml) is collected from patients in sterile container (EDTA tube) and will be sent for urine albumin creatinine ratio (ACR) and HbA1c test. The eye with best fundal and signal view on OCT-A will be chosen or if both eyes similar, right eye will be chosen. Pre-treatment tests fundus photo and OCT-A measurement will be taken at eye clinic after dilating the pupils with 1% tropicamide and 2.5% phenylephrine hydrochloride. Fundus examination is taken using a digital mydriatic retinal camera (Topcon Retinal Camera TRC-50DX (type 1A), Tokyo Japan. OCT-A measurement is taken by using Cirrus HD-OCT, 2016 Carl Zeiss Meditec.
Then Tab.empagliflozin 25mg once daily for 28 days will be given to both group of patients proteinuric and non proteinuric diabetic CKD. After 28 days, post-treatment tests of fundus examination and OCT-A measurement will be taken at eye clinic.
The statistical data analysis will be performed using statistical package for Social Science, version 22.0 (SPSS, Inc. Chicago III USA) for IOS. The OCT-A parameters studied (FAZ size, vessel density and perfusion density) will be used as main response variables. All variables will be defined by method of descriptive statistics. The analysis of quantitative variables includes a calculation of mean and standard deviation. T test will be performed to test the significant between the 2 groups. Correlation will be measured with Pearson correlation coefficient. A p <0.05 will be considered as statistically significant.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of Sodium Glucose co Transporter 2 (SGLT2) Inhibition on Optical Coherence Tomography Angiography (OCT-A) Parameters in Diabetic Chronic Kidney Disease (CKD) |
Actual Study Start Date : | December 1, 2019 |
Estimated Primary Completion Date : | May 2020 |
Estimated Study Completion Date : | August 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Proteinuric diabetic CKD
Tab.empagliflozin 25mg once daily for 28 days
|
Drug: Empagliflozin 25 MG
Tab.empagliflozin 25mg once daily for 28 days
Other Name: Jardiance Device: OCT-A Optical coherence tomography angiography (OCT-A) is a non-invasive method to study the microvasculature of the retina and choroid.
Other Name: Cirrus HD-OCT |
Active Comparator: Non-Proteinuric diabetic CKD
Tab.empagliflozin 25mg once daily for 28 days
|
Drug: Empagliflozin 25 MG
Tab.empagliflozin 25mg once daily for 28 days
Other Name: Jardiance Device: OCT-A Optical coherence tomography angiography (OCT-A) is a non-invasive method to study the microvasculature of the retina and choroid.
Other Name: Cirrus HD-OCT |
- Comparison of change in fovea avascular zone within retina of proteinuric and non-proteinuric chronic kidney disease patients treated with SGLT2-inhibitor [ Time Frame: After 28 days of treatment ]Change in fovea vascular zone (FAZ) size (um2) from Baseline using Optical Coherence Tomography Angiography (OCT-A) post-SGLT-2 treatment
- Comparison of change in retinal and choroidal vessel density in proteinuric and non-proteinuric chronic kidney disease patients treated with SGLT2-inhibitor [ Time Frame: After 28 days of treatment ]Change in vessel density (mm-1) from Baseline using Optical Coherence Tomography Angiography (OCT-A) post-SGLT-2 treatment
- Comparison of change in retinal and choroidal vascular perfusion density in proteinuric and non-proteinuric chronic kidney disease patients treated with SGLT2-inhibitor [ Time Frame: After 28 days of treatment ]Change in perfusion density from Baseline using Optical Coherence Tomography Angiography (OCT-A) post-SGLT-2 treatment

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Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients diagnosed with Type 2 DM with CKD (eGFR 45 - 60 ml/min/1.7m2)
- Age between 35 and 65 year old
- Patients able to give informed consent to participate in the study.
- Patients previously not on tablet Empagliflozin
Exclusion Criteria:
- Heart or respiratory failure, recent MI, shock, hypotension
- Pregnancy or lactation.
- Known case of CKD due to other causes such as hypertension, renal calculi, analgesic nephropathy
- Patients with multiple diuretic use.
- Hypersensitivity reactions to SGLT2 group of agents
- Patient underwent previous ocular intervention (surgery, laser or intraocular injection) within 3 months
- Dense cataract which could obscured the fundal view and signal strength on OCT-A
- HbA1c more than 10%
- Systolic blood pressure more than 180mmHg

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): NCT04215445
Contact: Wan Haslina Wan Abdul Halim, M.D | +6019-6679633 | afifiyad@yahoo.co.uk |
Malaysia | |
UKM Medical Centre | Recruiting |
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000 | |
Contact: Wan Haslina Wan Abdul Halim, M.D +6019-6679633 afifiyad@yahoo.co.uk | |
Principal Investigator: Wan Haslina Wan Abdul Halim, M.D | |
Sub-Investigator: Yong Meng Hsien, M.D | |
Sub-Investigator: Norasyikin A. Wahab, M.D | |
Sub-Investigator: Rozita Mohd, M.D | |
Sub-Investigator: Ruslinda Mustafar, M.D | |
Sub-Investigator: Siti Husna Hussein, M.D |
Study Chair: | Wan Haslina Wan Abdul Halim, M.D | Department of Ophthalmology, UKM Medical Centre |
Responsible Party: | Wan Haslina Wan Abdul Halim, Consultant Ophthalmologist-Cornea And Anterior Segment, National University of Malaysia |
ClinicalTrials.gov Identifier: | NCT04215445 |
Other Study ID Numbers: |
FF-2019-386 |
First Posted: | January 2, 2020 Key Record Dates |
Last Update Posted: | January 2, 2020 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Diabetic Retinopathy Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Empagliflozin Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |