Back to resultsA Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD (PHOENIX)
Primary Purpose
Neovascular Age-related Macular Degeneration
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Recombinant Human VEGF Receptor-Fc Fusion Protein
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902), age-related macular degeneration (AMD), choroidal neovascularization (CNV), intravitreal injection, best corrected visual acuity (BCVA), central retinal thickness
Eligibility Criteria
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;
Sites / Locations
- First Affiliated Hospital of Fujian Medical College
- Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
- People's Hospital of Wuhan University
- Wuhan General Hospital of Guangzhou Military Command
- Wuxi Second People's Hospital
- The First Hospital of China Medical University
- Ophthalmologic Hospital of Qingdao
- Eye & ENT Hospital of Fudan University
- Affiliated Hospital of Wenzhou Medical College
- Daping Hospital of the Third Military Medical University
- Shanghai First People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
0.5 mg KH902
Sham-injection
Arm Description
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)
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.
Outcomes
Primary Outcome Measures
Mean change from baseline in BCVA
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
Secondary Outcome Measures
The incidence rate of adverse event
To evaluate the difference in safety assessment between Conbercept (KH902) group and Sham group at month 3.
Mean change of retinal thickness from baseline
To evaluate the mean change of retinal thickness from baseline in KH902 treatment group or sham treatment group at month 3.
Full Information
NCT ID
NCT01436864
First Posted
September 19, 2011
Last Updated
April 13, 2023
Sponsor
Chengdu Kanghong Biotech Co., Ltd.
Collaborators
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01436864
Brief Title
A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD
Acronym
PHOENIX
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Kanghong Biotech Co., Ltd.
Collaborators
University of Wisconsin, Madison
4. Oversight
5. Study Description
Brief Summary
This study is designed to prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902), age-related macular degeneration (AMD), choroidal neovascularization (CNV), intravitreal injection, best corrected visual acuity (BCVA), central retinal thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.5 mg KH902
Arm Type
Experimental
Arm Description
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)
Arm Title
Sham-injection
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Recombinant Human VEGF Receptor-Fc Fusion Protein
Intervention Description
Intravitreal injection of KH902 once per month
Primary Outcome Measure Information:
Title
Mean change from baseline in BCVA
Description
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
Time Frame
at month 3
Secondary Outcome Measure Information:
Title
The incidence rate of adverse event
Description
To evaluate the difference in safety assessment between Conbercept (KH902) group and Sham group at month 3.
Time Frame
at month 3
Title
Mean change of retinal thickness from baseline
Description
To evaluate the mean change of retinal thickness from baseline in KH902 treatment group or sham treatment group at month 3.
Time Frame
at month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Xu
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Fujian Medical College
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
People's Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Wuhan General Hospital of Guangzhou Military Command
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Facility Name
Wuxi Second People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214002
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Ophthalmologic Hospital of Qingdao
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Facility Name
Daping Hospital of the Third Military Medical University
City
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
ZIP/Postal Code
200080
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD
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