Retinal and corneal neuroprotective effects of qiming granules or calcium dobesilate in patients with non-proliferative diabetic retinopathy
| ISRCTN | ISRCTN94680105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94680105 |
- Submission date
- 28/02/2023
- Registration date
- 04/03/2023
- Last edited
- 03/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Diabetic retinopathy (DR) is a complication of diabetes caused by high blood sugar levels damaging the back of the eye (retina). It is usually diagnosed and treated at a late stage when blood vessel changes occur, leading to poor effectiveness. Therefore, a new concept of DR treatment, which is targeted at nerve injury, needs to be established. This study aims to assess the effectiveness and safety of Qiming granules and calcium dobesilate (CAD) as an early intervention for nerve injury associated with non-proliferative DR (NPDR).
Who can participate?
Patients with NPDR
What does the study involve?
Participants are randomly allocated to receive Qiming granules or CAD or only basic treatment for 24 weeks. Peripapillary retinal nerve fiber layer (pRNFL) and corneal nerve fiber length (CNFL) are measured before and after 24 weeks of treatment.
What are the possible benefits and risks of participating?
It is expected that the participants can effectively control diabetic retinopathy and improve their quality of life. The important information obtained in this study may provide a theoretical basis for retinal nerve injury in patients and help to increase their own or other patients' treatment options. Participants may suffer side effects from the examination and drugs (for example, gastrointestinal adverse effects).
Where is the study run from?
The First Affiliated Hospital of Harbin Medical University (China)
When is the study starting and how long is it expected to run for?
September 2019 to January 2023
Who is funding the study?
The First Affiliated Hospital of Harbin Medical University (China)
Who is the main contact?
Prof Hongyu Kuang, ydykuanghongyu@126.com (China)
Contact information
Principal Investigator
No. 23 Postal Street
Nangang District
Heilongjiang Province
Harbin
150001
China
| Phone | +86 (0)13339300885 |
|---|---|
| ydykuanghongyu@126.com |
Scientific
No. 23 Postal Street
Nangang District
Heilongjiang Province
Harbin
150001
China
| Phone | +86(0)17380159637 |
|---|---|
| yangk0608@163.com |
Public
No. 23 Postal Street
Nangang District
Heilongjiang Province
Harbin
150001
China
| Phone | +86(0)17380159637 |
|---|---|
| yangk0608@163.com |
Study information
| Study design | Single-center single-blinded randomized active-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effects of qiming granules or calcium desolate on the peripapillary retinal nerve fiber layer thickness and corneal nerve parameters in patients with non-proliferative diabetic retinopathy |
| Study objectives | Qiming granules or calcium dobesilate can improve retinal neurodegeneration and microvascular changes as well as corneal nerve injury in patients with non-proliferative diabetic retinopathy (NPDR). |
| Ethics approval(s) | Approved 20/12/2019, Ethics Committee of the First Affiliated Hospital of Harbin Medical University (No. 23 Postal Street, Nangang District, Harbin City, Heilongjiang Province, China; +86 (0)451-85552350; black9090@163.com), ref: 2019152 |
| Health condition(s) or problem(s) studied | Non-proliferative diabetic retinopathy |
| Intervention | The participants were randomized approximately 1:1:1 to three groups by a random number table. The participants in the Qiming granule group receive Qiming granules (Zhejiang Wansheng Pharmaceutical Co., Ltd., Hangzhou, China, 4.5 g) mixed with boiling water three times a day for 24 weeks. The participants in the CAD group receive calcium dobesilate capsules (Ebewe Pharma GmbH, Unterach am Attersee, Austria, 0.5 g) three times a day for 24 weeks. The participants in the control group only receive basic treatment such as controlling blood glucose, blood pressure and blood lipid for 24 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Qiming granules, calcium dobesilate capsules |
| Primary outcome measure | 1. Peripapillary retinal nerve fiber layer (pRNFL) thickness measured using optical coherence tomography angiography (OCTA) at baseline and 24 weeks 2. Corneal nerve fiber length (CNFL) measured using corneal confocal microscopy (CCM) at baseline and 24 weeks |
| Secondary outcome measures | 1. Corneal nerve fiber density (CNFD) and corneal nerve branch density (CNBD) measured using CCM at baseline and 24 weeks 2. Foveal avascular zone (FAZ) area measured using OCTA at baseline and 24 weeks 3. Best corrected visual acuity ( BCVA) measured using international standard vision chart at baseline and 24 weeks |
| Overall study start date | 01/09/2019 |
| Completion date | 31/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 30 patients were randomized approximately 1:1:1 to three groups by random number table： |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Aged 18-70 years old (including boundary value) 2. Patients diagnosed with Type 2 diabetes(according to 1999 WHO criterion) 3. Patients with non-proliferative diabetic retinopathy (NPDR) (According to fundus photography and International Clinical Classification Standard for diabetes Retinopathy (2002)) 4. Subjects were treated with stable hypoglycemic drugs for at least 3 months 5. Subjects signed informed consent |
| Key exclusion criteria | 1. Subjects with other non-diabetic eye diseases interfering with fundus examination results (such as glaucoma, cataract, non-diabetic hemorrhagic eye disease, uveitis, retinal detachment, optic nerve disease, refractive stromal abnormalities, etc.) 2. Subjects with proliferative retinopathy (PDR) 3. glycosylated hemoglobin (HbA1C)＞8.0% 4. Subjects with diabetic retinopathy caused by type 1 and special types of diabetes 5. Subjects who underwent eye surgery or treatment within 6 months 6. Subjects with central nervous system diseases 7. Subjects suffering from allergic diseases or allergic to this medicine 8. Subjects participated in other drugs trials within 3 months 9. Subjects were treated with drugs for diabetic retinopathy 10. Uncontrolled hypertension or untreated hypertension(defined as systolic blood pressure(SBP)＞160mmHg or diastolic blood pressure(DBP)＞100mmHg during screening) 11. Severe systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, genitourinary system diseases, etc.), malignant tumors, mental diseases and other diseases that may interfere with the results of this study 12. Impaired liver function, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 2.5 times the upper limit of normal value 13. Renal insufficiency (eGFR<45ml/min) 14. Women who are pregnant, breastfeeding or preparing for pregnancy 15. Subjects suffering from cancer requiring treatment in the past five years or expected to die within five years 16. Unwilling to sign informed consent 17. Subjects who cannot take medication as planned, and those who are unwilling or unable to accept regular visits |
| Date of first enrolment | 01/02/2020 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- China
Study participating centre
061011
China
Sponsor information
Hospital/treatment centre
No. 23 Postal Street
Nangang District
Heilongjiang Province
Harbin
150001
China
| Phone | +86(0)451 53643849 |
|---|---|
| kykbgs123@163.com | |
| Website | https://www.54dr.org.cn/ |
"ROR" |
https://ror.org/05vy2sc54 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the principle of informed consent which indicated that the patient's personal data will not be public. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 01/09/2020 | 03/03/2023 | No | No |
Additional files
Editorial Notes
03/03/2023: Trial's existence confirmed by the Ethics Committee of the First Affiliated Hospital of Harbin Medical University (China).
