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

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

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.

Study Overview

• Status: Unknown
• Conditions: Moderately Severe to Severe NPDR
• Intervention / Treatment: Drug: Keluo Xin capsule; Drug: Placebo oral capsule

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.

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yanping Song, Professor; Phone Number: +86-27-50772574; Email: songyanping@medmail.com.cn
• Study Contact Backup: Name: Quan Wu; Phone Number: +86-28-87516605; Email: wuquan@cnkh.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of retinal blood flow density	A exploratory objective which will be evaluated by angio OCT.	Baseline and 24 weeks
Change of retinal blood flow density	A exploratory objective which will be evaluated by angio OCT.	Baseline and 48 weeks

Collaborators and Investigators

• Sponsor: Chengdu Kanghong Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yanping Song, Professor, Wuhan General Hospital of Guangzhou Military, China

Publications and helpful links

General Publications

• 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.
• American Academy of Ophthalmology, "Diabetic retinopathy.," 2014.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2017
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): February 28, 2020

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 20, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: KH105-B02-CRP-2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No