Diabetic Macular EdemaPhase 1/2Frontier-1NCT01324869
Safety and Efficacy by Multiple Injection of KH902 in Patients With Diabetic Macular Edema (DME)
A Phase 1/2 study testing KH902 in people with Diabetic Macular Edema, run by Chengdu Kanghong Biotech Co., Ltd. at 1 site in China.
Trial summary
This study is designed to access the safety and efficacy of multiple injections of KH902 in patients with Diabetic Macular Edema (DME). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- KH902
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Oct 2012
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the Informed Consent Form and willing to comply with study procedures;
- 18 years old ≦ either gender ≦ 75 years old;
- Confirmed diagnosed with Type 1 diabetes or Type 2 diabetes based on the diabetes diagnosis criteria;
- Clinically significant DME:
- Hard exudation within 500μm of the central foveal diameter accompanied with contiguous retina thickening;
- The edema locates within 500μm of the central foveal diameter;
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- Retina thickening field > 1DD and within the 1DD central fovea.
- BCVA score of the study eyes between 78 and 19 letters, inclusively, and the BCVA score of fellow eyes ≥ 24 letters;
- Previous treatment of antidiabetic drugs within three months preceding the screening, and blood-glucose concentration is predicted to be unchanged and stable during the whole study.
Who cannot join
- Uncontrolled glaucoma in either eye;
- Currently active ocular inflammation or infection in either eye;
- Macular edema in the study eye was caused by other diseases rather than diabetes;
- Company with any other ocular conditions failing to prevent vision loss despite improving the macular edema;
- Any other ocular diseases which may cause macular edema or vision alteration during study phase;
- Retinal macular traction or macular epiretinal membrane in study eye;
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- Refractive error equate or exceed 8 diopters of myopia in study eye
- Whole or regional retinal laser photocoagulation has been applied in study eye within 6 months preceding the screening;
- Previous anti-VEGF drug treatment in study eye;
- Intraocular or periocular injection of steroid drug within 6 months preceding the screening;
- Previous ophthalmologic operation within 3 months preceding the screening and/or planning to receive an ophthalmologic operation during the study.
- There is any potential for the study eye to receive the panretinal laser photocoagulation treatment during the study;
- Previous vitrectomy in study eye.
- Uncontrolled diabetes;
- Hypertensive patients with poorly controlled blood pressure;
- Uncontrolled systemic infectious diseases;
- Systemic immune diseases;
- History of allergy;
- Any uncontrolled clinical disorders;
- Pregnant or nursing women;
- Adopt one or more adequate contraception methods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Uncontrolled, Preliminary Clinical Study to Evaluate the Safety and Efficacy of KH902 Following Multiple Intravitreal Injection in Patients With Diabetic Macular Edema
This study is designed to access the safety and efficacy of multiple injections of KH902 in patients with Diabetic Macular Edema (DME).
Read the detailed description
With improvement of our living standard, patients who suffered from Diabetes become more and more. As the investigators know, Diabetes can induce many ocular diseases leading to vision loss. And according to observations, DME is diagnosed as one main cause of vision loss in the patients with Diabetes.
As the results of many studies conducted previously, anti-VEGF drugs and anti-VEGF treatments show its effect and safety not only in treating AMD, but also in patients with DME. The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The previous clinical trials of KH902 show that KH902 is effective and safe in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF. Due to these positive results, the investigators prepare to conduct a clinical trial to assess the safety and efficacy with intravitreal injection of KH902 in patients with DME.
- Conditions
- Diabetic Macular Edema
- Being tested
- KH902
- Keywords
- KH902, Diabetic macular Edema, Intravitreal injection, Multiple injections, 20 patients, 0.5mg/eye/time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH902Biological
Intravitreal injection of 0.5mg/eye/time KH902
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will receive an intravitreal injection of 0.5mg KH902 in the study eye at the first month, following the fixed injection, patients will continue to receive injection of KH902 at the same dose on an as needed (PRN) dosing schedule based upon the monthly physician assessment of the need for re-treatment in accordance with pre-specified criteria. Receives: Biological: KH902 |
| Group B | Experimental | Patients will receive continuously monthly intravitreal injections of 0.5 mg KH902 for 3 times in the study eye; following the initial 3-month fixed-dosing phase of the trial, patients will continue to receive injection of KH902 at the same dose on an as needed (PRN) dosing schedule based upon the monthly physician assessment of the need for re-treatment in accordance with pre-specified criteria. Receives: Biological: KH902 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adverse event
To evaluate the safety of multiple intravitreal injection of KH902 to treat DME.
Measured: up to 12 months
Secondary outcomes (1)
Change from Baseline in BCVA
To evaluate the efficacy of multiple intravitreal injection of KH902 of each group.
Measured: at the end of month 3 and the end of month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison, Teaching and Research Office of Health Statistics, Fourth Military Medical University
- Responsible party
- Sponsor
- Investigators
- Xun Xu, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineLun De Luo, Study director, Chengdu Kanghong Biotech Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324869
- Sponsor's protocol ID
- KHSWKH902002
- Acronym
- Frontier-1
- Status last verified
- Feb 2013
- First submitted
- 15 Mar 2011
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Uncontrolled, Preliminary Clinical Study to Evaluate the Safety and Efficacy of KH902 Following Multiple Intravitreal Injection in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01324869
- Acronym / sponsor ID
- Frontier-1 / KHSWKH902002
- Conditions
- Diabetic Macular Edema
- Keywords
- KH902, Diabetic macular Edema, Intravitreal injection, Multiple injections, 20 patients, 0.5mg/eye/time
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison, Teaching and Research Office of Health Statistics, Fourth Military Medical University
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Mar 2011 (estimated)
- 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 study is designed to access the safety and efficacy of multiple injections of KH902 in patients with Diabetic Macular Edema (DME).
Detailed description
With improvement of our living standard, patients who suffered from Diabetes become more and more. As the investigators know, Diabetes can induce many ocular diseases leading to vision loss. And according to observations, DME is diagnosed as one main cause of vision loss in the patients with Diabetes.
As the results of many studies conducted previously, anti-VEGF drugs and anti-VEGF treatments show its effect and safety not only in treating AMD, but also in patients with DME. The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The previous clinical trials of KH902 show that KH902 is effective and safe in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF. Due to these positive results, the investigators prepare to conduct a clinical trial to assess the safety and efficacy with intravitreal injection of KH902 in patients with DME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: KH902Patients will receive an intravitreal injection of 0.5mg KH902 in the study eye at the first month, following the fixed injection, patients will continue to receive injection of KH902 at the same dose on an as needed (PRN) dosing schedule based upon the monthly physician assessment of the need for re-treatment in accordance with pre-specified criteria. |
| Group B | Experimental | Biological: KH902Patients will receive continuously monthly intravitreal injections of 0.5 mg KH902 for 3 times in the study eye; following the initial 3-month fixed-dosing phase of the trial, patients will continue to receive injection of KH902 at the same dose on an as needed (PRN) dosing schedule based upon the monthly physician assessment of the need for re-treatment in accordance with pre-specified criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed the Informed Consent Form and willing to comply with study procedures;
- 18 years old ≦ either gender ≦ 75 years old;
- Confirmed diagnosed with Type 1 diabetes or Type 2 diabetes based on the diabetes diagnosis criteria;
- Clinically significant DME:
- BCVA score of the study eyes between 78 and 19 letters, inclusively, and the BCVA score of fellow eyes ≥ 24 letters;
Key exclusion criteria (21 listed)
- Uncontrolled glaucoma in either eye;
- Currently active ocular inflammation or infection in either eye;
- Macular edema in the study eye was caused by other diseases rather than diabetes;
- Company with any other ocular conditions failing to prevent vision loss despite improving the macular edema;
- Any other ocular diseases which may cause macular edema or vision alteration during study phase;
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 |
|---|---|---|
| KH902Intravitreal injection of 0.5mg/eye/time KH902 | Biological | Group A, Group B |
Primary outcome
Incidence rate of adverse event
Time frame: up to 12 months
To evaluate the safety of multiple intravitreal injection of KH902 to treat DME.
1 secondary outcome
Change from Baseline in BCVA
Time frame: at the end of month 3 and the end of month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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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.
Xun Xu principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lun De Luo study director
Chengdu Kanghong Biotech Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KH902 in people with Diabetic Macular Edema, run by Chengdu Kanghong Biotech Co., Ltd. at 1 site in China.
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 9 inclusion and 21 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: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of adverse event (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2013.