Moderately Severe to Severe NPDRPhase 2NCT03258242
A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy
A Phase 2 study testing Keluo Xin capsule in people with Moderately Severe to Severe NPDR, run by Chengdu Kanghong Pharmaceutical Co., Ltd..
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderately Severe to Severe NPDR
- What is being tested?
- Keluo Xin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2017to 28 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Moderately Severe to Severe NPDR
- Being tested
- Keluo Xin capsule, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keluo Xin capsuleDrug
four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
Placebo oral capsuleDrug
four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Keluo Xin Capsule | Experimental | Not described Receives: Drug: Keluo Xin capsule |
| Placebo Comparator: Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 48 weeks
Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
Measured: Baseline and 24 weeks
Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
Measured: Baseline and 48 weeks
Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
Measured: Baseline and 24 weeks
Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
Measured: 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.
Measured: 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.
Measured: Baseline and 48 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: Baseline and 48 weeks
Frequency and severity of ocular and non-ocular adverse events over time
Measured: Screening to 24 weeks and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start31 Aug 2017 (estimated)
- Primary completion31 Aug 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderately Severe to Severe NPDRStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanping Song, Professor, Principal investigator, Wuhan General Hospital of Guangzhou Military, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258242
- Sponsor's protocol ID
- KH105-B02-CRP-2.0
- Status last verified
- Aug 2017
- First submitted
- 4 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24002281
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Multicenter, Placebo Controlled Study of Keluo Xin Capsule on Efficacy and Safety in Patients With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03258242
- Acronym / sponsor ID
- KH105-B02-CRP-2.0
- Conditions
- Moderately Severe to Severe NPDR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2017 (estimated)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Keluo Xin Capsule | Experimental | Drug: Keluo Xin capsule |
| Placebo Comparator: Placebo | Placebo comparator | Drug: Placebo oral capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keluo Xin capsulefour capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks. | Drug | Experimental: Keluo Xin Capsule |
| Placebo oral capsulefour placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks. | Drug | Placebo Comparator: Placebo |
Primary outcome
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.
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.
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 48 weeks as measured by optical coherence tomography (OCT) .
Time frame: Baseline and 48 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 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.
3 secondary outcomes
Mean change from baseline in best corrected visual acuity at 24 weeks
Time frame: Baseline and 24 weeks
Mean change from baseline in best corrected visual acuity at 48 weeks
Time frame: Baseline and 48 weeks
Frequency and severity of ocular and non-ocular adverse events over time
Time frame: Screening to 24 weeks and 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- BackgroundAmerican Academy of Ophthalmology, "Diabetic retinopathy.," 2014.
- Background: PubMed 24002281Xu 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanping Song, Professor principal investigator
Wuhan General Hospital of Guangzhou Military, China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Keluo Xin capsule in people with Moderately Severe to Severe NPDR, run by Chengdu Kanghong Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanping Song, Professor (+86-27-50772574, songyanping@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks (time frame: Baseline and 24 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258242, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.