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

Moderately Severe to Severe NPDR Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03258242
• Other study ID #: KH105-B02-CRP-2.0
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 4, 2017
• Last updated: August 22, 2017
• Start date: August 31, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: August 2017
• Source: Chengdu Kanghong Pharmaceutical Co., Ltd.
• Contact: Yanping Song, Professor
• Phone: +86-27-50772574
• Email: songyanping[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 198
• Est. completion date: February 28, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Moderately Severe to Severe NPDR

Intervention

Drug:
• Keluo Xin capsule
four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
• Placebo oral capsule
four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Kanghong Pharmaceutical Co., Ltd.

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of retinal blood flow density	A exploratory objective which will be evaluated by angio OCT.	Baseline and 24 weeks
Other	Change of retinal blood flow density	A exploratory objective which will be evaluated by angio OCT.	Baseline and 48 weeks
Primary	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
Primary	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
Primary	Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .		Baseline and 24 weeks
Primary	Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .		Baseline and 48 weeks
Primary	Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).		Baseline and 24 weeks
Primary	Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).		Baseline and 48 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	Frequency and severity of ocular and non-ocular adverse events over time		Screening to 24 weeks and 48 weeks