A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy
Primary Purpose
Moderately Severe to Severe NPDR
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Keluo Xin capsule
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Moderately Severe to Severe NPDR
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental: Keluo Xin Capsule
Placebo Comparator: Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
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.
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.
Secondary Outcome Measures
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.
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.
Frequency and severity of ocular and non-ocular adverse events over time
Full Information
NCT ID
NCT03258242
First Posted
August 4, 2017
Last Updated
August 22, 2017
Sponsor
Chengdu Kanghong Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03258242
Brief Title
A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy
Official Title
A Randomized, Double-masked, Multicenter, Placebo Controlled Study of Keluo Xin Capsule on Efficacy and Safety in Patients With Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2017 (Anticipated)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Kanghong Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderately Severe to Severe NPDR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Keluo Xin Capsule
Arm Type
Experimental
Arm Title
Placebo Comparator: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Keluo Xin capsule
Intervention Description
four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
Primary Outcome Measure Information:
Title
Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks
Description
Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
Time Frame
Baseline and 24 weeks
Title
Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks
Description
Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
Time Frame
Baseline and 48 weeks
Title
Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
Time Frame
Baseline and 24 weeks
Title
Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
Time Frame
Baseline and 48 weeks
Title
Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
Time Frame
Baseline and 24 weeks
Title
Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
Time Frame
Baseline and 48 weeks
Title
Mean change from baseline in Chinese medicine syndrome score chart at 24 weeks
Description
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.
Time Frame
Baseline and 24 weeks
Title
Mean change from baseline in Chinese medicine syndrome score chart at 48 weeks
Description
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.
Time Frame
Baseline and 48 weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline in best corrected visual acuity at 24 weeks
Description
Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Time Frame
Baseline and 24 weeks
Title
Mean change from baseline in best corrected visual acuity at 48 weeks
Description
Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Time Frame
Baseline and 48 weeks
Title
Frequency and severity of ocular and non-ocular adverse events over time
Time Frame
Screening to 24 weeks and 48 weeks
Other Pre-specified Outcome Measures:
Title
Change of retinal blood flow density
Description
A exploratory objective which will be evaluated by angio OCT.
Time Frame
Baseline and 24 weeks
Title
Change of retinal blood flow density
Description
A exploratory objective which will be evaluated by angio OCT.
Time Frame
Baseline and 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanping Song, Professor
Phone
+86-27-50772574
Email
songyanping@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Wu
Phone
+86-28-87516605
Email
wuquan@cnkh.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanping Song, Professor
Organizational Affiliation
Wuhan General Hospital of Guangzhou Military, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
American Academy of Ophthalmology, "Diabetic retinopathy.," 2014.
Results Reference
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PubMed Identifier
24002281
Citation
Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.
Results Reference
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A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy
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