A Randomized, Double-masked, Multicenter, Placebo Controlled Study of Keluo Xin Capsule on Efficacy and Safety in Patients With Diabetic Retinopathy
Overview
- Phase
- Phase 2
- Enrollment
- 198
- Primary Endpoint
- Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experimental: Keluo Xin Capsule
Intervention: Keluo Xin capsule (Drug)
Placebo Comparator: Placebo
Intervention: Placebo oral capsule (Drug)
Outcomes
Primary Outcomes
Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
Time Frame: Baseline and 24 weeks
Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
Time Frame: Baseline and 24 weeks
Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
Time Frame: Baseline and 48 weeks
Mean change from baseline in Chinese medicine syndrome score chart at 24 weeks
Time Frame: Baseline and 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 DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks
Time Frame: Baseline and 24 weeks
Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
Time Frame: Baseline and 48 weeks
Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks
Time Frame: Baseline and 48 weeks
Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
Mean change from baseline in Chinese medicine syndrome score chart at 48 weeks
Time Frame: Baseline and 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 Outcomes
- Mean change from baseline in best corrected visual acuity at 24 weeks(Baseline and 24 weeks)
- Mean change from baseline in best corrected visual acuity at 48 weeks(Baseline and 48 weeks)
- Frequency and severity of ocular and non-ocular adverse events over time(Screening to 24 weeks and 48 weeks)