A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-masked, Multicenter, Placebo Controlled Study of Keluo Xin Capsule on Efficacy and Safety in Patients With Diabetic Retinopathy

Conditions
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Moderately Severe to Severe NPDR

Intervention / Treatment
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* Drug: Keluo Xin capsule
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Keluo Xin Capsule<br> | Drug: Keluo Xin capsule<br>* four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.<br>|
| Placebo Comparator: Placebo Comparator: Placebo<br> | Drug: Placebo oral capsule<br>* four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks | Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity. | Baseline and 24 weeks | 
| Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks | Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity. | Baseline and 48 weeks | 
| Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) . |  | Baseline and 24 weeks | 
| 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 | 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. | Baseline and 24 weeks | 
| Mean change from baseline in Chinese medicine syndrome score chart at 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. | Baseline and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in best corrected visual acuity at 24 weeks | Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. | Baseline and 24 weeks | 
| Mean change from baseline in best corrected visual acuity at 48 weeks | Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. | Baseline and 48 weeks | 
| Frequency and severity of ocular and non-ocular adverse events over time |  | Screening to 24 weeks and 48 weeks |