Moderately Severe to Severe NPDR
Conditions
Brief summary
This is a study aiming to assess the efficacy and safety of Keluo Xin capsule in patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR). Two-thirds of participates will receive Keluo Xin capsules while other one third will receive placebo.
Detailed description
This study composes two parts. The first is a 24-week period during which subjects receive designed treatment regimen; after that, subjects will be informed again for the next 24-week regimen (extention phase) and can choose whether or not to participate in the treatment (with the same regimen in the first period) voluntarily.
Interventions
DRUGKeluo Xin capsule
four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
DRUGPlacebo oral capsule
four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
Sponsors
Chengdu Kanghong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18 years to 70 years; * Patients diagnosed with type 2 diabetes mellitus; * Patients diagnosed with nonproliferative diabetic retinopathy; * Patients diagnosed with traditional Chinese medicine syndrome(TCM) differentiation of both Qi and Yin deficiency with blood Stasis; * HbA1c≤8.0%;
Exclusion criteria
* Study eye been received panretinal photocoagulation; * Study eye with neovascular elsewhere or neovascular of the disc, or neovascularization of iris; * Prior panretinal photocoagulation in the study eye within 6 months; * Uncontrolled blood pressure; * Subjects who develop chronic diarrhoea; * Any history of acute diabetic complications; * Any history of allergy to components of Keluo Xin capsule; * Pregnant or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in Chinese medicine syndrome score chart at 48 weeks | Baseline and 48 weeks | The score chart is based on the typical symptoms and signs both in the eye and whole body on patients with DR and is used to assess DR severity. |
| Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) . | Baseline and 48 weeks | — |
| Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA). | Baseline and 24 weeks | — |
| Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA). | Baseline and 48 weeks | — |
| Mean change from baseline in Chinese medicine syndrome score chart at 24 weeks | Baseline and 24 weeks | The score chart is based on the typical symptoms and signs both in the eye and whole body on patients with DR and is used to assess DR severity. |
| Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks | Baseline and 24 weeks | Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity. |
| Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks | Baseline and 48 weeks | Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity. |
| Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) . | Baseline and 24 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in best corrected visual acuity at 24 weeks | Baseline and 24 weeks | Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. |
| Mean change from baseline in best corrected visual acuity at 48 weeks | Baseline and 48 weeks | Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. |
| Frequency and severity of ocular and non-ocular adverse events over time | Screening to 24 weeks and 48 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of retinal blood flow density | Baseline and 24 weeks | A exploratory objective which will be evaluated by angio OCT. |
Contacts
Primary ContactYanping Song, Professor
Backup ContactQuan Wu
Outcome results
None listed