A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD (PHOENIX)

This study has been completed.
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01436864
First received: September 19, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Neovascular Age-related Macular Degeneration
Biological: Recombinant Human VEGF Receptor-Fc Fusion Protein
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chengdu Kanghong Biotech Co.,Ltd.:

Primary Outcome Measures:
  • Mean change from baseline in BCVA [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: at month 3 ] [ Designated as safety issue: Yes ]
    To evaluate the difference in safety assessment between Conbercept (KH902) group and Sham group at month 3.

  • Mean change of retinal thickness from baseline [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    To evaluate the mean change of retinal thickness from baseline in KH902 treatment group or sham treatment group at month 3.


Enrollment: 125
Study Start Date: August 2011
Study Completion Date: November 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Biological: Recombinant Human VEGF Receptor-Fc Fusion Protein
Intravitreal injection of KH902 once per month
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.
Biological: Recombinant Human VEGF Receptor-Fc Fusion Protein
Intravitreal injection of KH902 once per month

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436864

Locations
China, Fujian
First Affiliated Hospital of Fujian Medical College
Fuzhou, Fujian, China, 350005
China, Guangdong
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, China, 515041
China, Hubei
Wuhan General Hospital of Guangzhou Military Command
Wuhan, Hubei, China, 430070
People's Hospital of Wuhan University
Wuhan, Hubei, China, 430060
China, Jiangsu
Wuxi Second People's Hospital
Wuxi, Jiangsu, China, 214002
China, Liaoning
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
China, Shandong
Ophthalmologic Hospital of Qingdao
Qingdao, Shandong, China, 266071
China, Shanghai
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai, China, 200031
China, Zhejiang
Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China, 325027
China
Daping Hospital of the Third Military Medical University
Chongqing, China, 400042
Shanghai First People's Hospital
Shanghai, China, 200080
Sponsors and Collaborators
Chengdu Kanghong Biotech Co.,Ltd.
University of Wisconsin, Madison
Investigators
Principal Investigator: Xun Xu Shanghai First People's Hospital
  More Information

No publications provided

Responsible Party: Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01436864     History of Changes
Other Study ID Numbers: KHSWKH902005
Study First Received: September 19, 2011
Last Updated: March 21, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Chengdu Kanghong Biotech Co.,Ltd.:
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

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014