Clinical trial NCT03258242: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Moderately Severe to Severe NPDR
Lead sponsor: Chengdu Kanghong Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-23
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks
timeFrame: Baseline and 24 weeks
measure: Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks
timeFrame: Baseline and 48 weeks
measure: Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
timeFrame: Baseline and 24 weeks
measure: Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
timeFrame: Baseline and 48 weeks
measure: Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
timeFrame: Baseline and 24 weeks
measure: Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
timeFrame: Baseline and 48 weeks
measure: Mean change from baseline in Chinese medicine syndrome score chart at 24 weeks
timeFrame: Baseline and 24 weeks
measure: Mean change from baseline in Chinese medicine syndrome score chart at 48 weeks
timeFrame: Baseline and 48 weeks
Secondary outcomes:
measure: Mean change from baseline in best corrected visual acuity at 24 weeks
timeFrame: Baseline and 24 weeks
measure: Mean change from baseline in best corrected visual acuity at 48 weeks
timeFrame: Baseline and 48 weeks
measure: Frequency and severity of ocular and non-ocular adverse events over time
timeFrame: Screening to 24 weeks and 48 weeks
Other outcomes:
measure: Change of retinal blood flow density
timeFrame: Baseline and 24 weeks
measure: Change of retinal blood flow density
timeFrame: Baseline and 48 weeks
Locations:
Study officials:
affiliation: Wuhan General Hospital of Guangzhou Military, China
name: Yanping Song, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Academy of Ophthalmology, "Diabetic retinopathy.," 2014.
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.