- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01436864
A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD (PHOENIX)
A Phase 3 Clinical Trial of Intravitreal Injections of Human Recombinant Vascular Endothelial Growth Factor Receptor-Fc Fusion Protein in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
AMD is the leading cause of severe vision loss in people over the age of 65 in the United States and other western countries. A quantity of documents indicate that neovascularization promoted by VEGF is the main cause of visual acuity decline. Patients are starving for a new drug which can notably improve VA with less administration frequency and lower treatment cost.
The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The pre-clinical researches and phase II study showed that KH902 is well-tolerated,and safe, it is effective in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF.
This study is designed to prove and confirm the efficacy and safety of multiple injections of KH902 in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Chongqing, China, 400042
- Daping Hospital of the Third Military Medical University
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Shanghai, China, 200080
- Shanghai First People's Hospital
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Fujian
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Fuzhou, Fujian, China, 350005
- First Affiliated Hospital of Fujian Medical College
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Guangdong
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Shantou, Guangdong, China, 515041
- Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
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Hubei
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Wuhan, Hubei, China, 430060
- People's Hospital of Wuhan University
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Wuhan, Hubei, China, 430070
- Wuhan General Hospital of Guangzhou Military Command
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Jiangsu
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Wuxi, Jiangsu, China, 214002
- Wuxi Second People's Hospital
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Liaoning
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Shenyang, Liaoning, China, 110001
- The First Hospital of China Medical University
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Shandong
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Qingdao, Shandong, China, 266071
- Ophthalmologic Hospital of Qingdao
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Shanghai
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Shanghai, Shanghai, China, 200031
- Eye & ENT Hospital of Fudan University
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Zhejiang
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Wenzhou, Zhejiang, China, 325027
- Affiliated Hospital of Wenzhou Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed the Informed Consent Form;
- Age ≥ 50 years of either gender;
- Total lesion size ≤ 30 mm2 of the study eye;
- BCVA score of the study eye between 73 and 19 letters;
- Clear ocular media and adequate pupil dilation to permit good quality fundus photographic imaging.
- BCVA score of the fellow eye ≥ 19 letters.
Exclusion Criteria:
- Current or previous non-exudative AMD diseases which affect the inspection and measurement of macular or the central visual acuity;
- Subretinal hemorrhage area≥ 50% of total lesion size;
- Scar or fibrosis area in study eyes ≥ 50% of total lesion size; or central foveal scar、fibrosis or atrophy of macular in the study eye;
- Presence of retinal pigment epithelial tear, retinal macular tractional, macular epiretinal membrane, and diagnosed with polypoidal choroidal vasculopathy in the study eye;
- Previous anti-VEGF drug treatment in the study eye within six months preceding screening; or anti-VEGF treatment in the fellow eye within three months before screening;
- Previous intraocular or periocular operations, excluding operations on eyelid without hampering the intravitreal injection in the study eye;
- Previous ophthalmologic operations in the study eye;
- Current active inflammation or infection in either eye;
- Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
- Current systemic administrations which may lead to toxicity in the crystalline lens;
- History of allergy or current allergic response;
- History of surgery within one month preceding enrollment;
- Infectious diseases need systemic administration;
- Systemic autoimmune diseases;
- Any uncontrolled clinical disorders;
- Patients of child-bearing potential do not adopted adequate contraception methods;
- Pregnant or nursing women;
- Patients should be excluded in the opinion of investigators;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.5 mg KH902
Patients will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, and then patients will receive 2 sham injections monthly, respectively, at the end of month 3 (visit 5), and following these injections you will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 5, month 8 and month 11)
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Intravitreal injection of KH902 once per month
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Sham Comparator: Sham-injection
Patients will receive sham injection once per month for three times, and then you will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, after three months' treatment they will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 8 and month 11.
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Intravitreal injection of KH902 once per month
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change from baseline in BCVA
Time Frame: at month 3
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To evaluate the mean change from baseline in best-corrected visual acuity (BCVA) in KH902 treatment group and sham treatment group at month 3 and compare the difference between the values
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at month 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence rate of adverse event
Time Frame: at month 3
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To evaluate the difference in safety assessment between Conbercept (KH902) group and Sham group at month 3.
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at month 3
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Mean change of retinal thickness from baseline
Time Frame: at month 3
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To evaluate the mean change of retinal thickness from baseline in KH902 treatment group or sham treatment group at month 3.
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at month 3
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Xun Xu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHSWKH902005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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