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A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular AMD (AURORA)

This study has been completed.
Sponsor:
Collaborators:
Beijing DMS Pharma Ltd.
Digital Angiography Reading Center
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01157715
First received: July 6, 2010
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

This study is designed to access the safety and efficacy of multiple injections of KH902 at variable dosing regimens in patients with CNV due to neovascular AMD.


Condition Intervention Phase
Neovascular Age-related Macular Degeneration
 Biological: intravitreal injection of KH902
 Phase 2

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 Randomized, Double-masked, Multicenter, Controlled Dose- and Interval-ranging Clinical Study of Intravitreal Injection of KH902 in Patients With Neovascular Age-related Macular Degeneration (the AURORA Study)

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change from baseline in BCVA [ Time Frame: at 3-month ] [ Designated as safety issue: No ]
  • The incidence rate of adverse event [ Time Frame: at 3-month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in central retinal thickness [ Time Frame: at 3-month and 12-month ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: May 2010
Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5 mg cohort
patients will receive 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 be randomized in a 1:1 ratio into one of two groups as follows: i. q1m group: patients will continue to receive monthly intravitreal injections of KH902 at the same dose received during the fixed dosing phase; ii. prn group: patients will continue to receive injection of KH902 at the same dose received during the fixed dosing phase, on an as needed (PRN) dosing schedule based upon the physician assessment of the need for re-treatment in accordance with pre-specified criteria .
 Biological: intravitreal injection of KH902
Experimental: 2.0 mg cohort
patients will receive monthly intravitreal injections of 2.0 mg KH902 for 3 times in the study eye;following the initial 3-month fixed-dosing phase of the trial, patients will be randomized in a 1:1 ratio into one of two groups as follows: i. q1m group: patients will continue to receive monthly intravitreal injections of KH902 at the same dose received during the fixed dosing phase; ii. prn group: patients will continue to receive injection of KH902 at the same dose received during the fixed dosing phase, on an as needed (PRN) dosing schedule based upon the physician assessment of the need for re-treatment in accordance with pre-specified criteria .
 Biological: intravitreal injection of KH902

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 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 I study show that KH902 is effective and safe in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF.

This study is designed to confirm the efficacy and safety of multiple injections of KH902 at variable dosing regimen in patients with CNV due to neovascular AMD. Based on the characteristics of KH902 and results from KH902 Phase I study as well as reference to clinical trials of similar drugs, it is determined that KH902 is administrated at 0.5mg/eye/time and 2.0mg/eye/time.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Signed the ICF; Age ≥ 50 years of either gender;
  • Active primary or recurrent lesions with subfoveal or juxtafoveal CNV secondary to neovascular AMD in the study eye;
  • Lesion size ≤ 12 disc areas in either eye;
  • BCVA of the study eyes between 73 and 24 letters, inclusively, and the BCVA of fellow eyes ≥ 19 letters;
  • Clear ocular media and adequate pupil dilation.
  • If both eyes were eligible, only one was selected.

Exclusion criteria:

  • History of vitreous hemorrhage, retinal detachment or macular hole, presence of retinal pigment epithelial tear, retinal macular traction or macular epiretinal membrane, and PCV in the study eye;
  • Subfoveal scar or atrophy in the study eye;
  • Subretinal hemorrhage in the study eye;
  • Uncontrolled glaucoma in either eye;
  • Active inflammation or infection in either eye;
  • Previous drug treatment, either anti-VEGF drugs or steroid derivatives, and/or, previous ophthalmologic operation or laser therapy in the study eye;
  • History of surgery within one month preceding enrollment;
  • Any uncontrolled clinical disorders;
  • Patients of child-bearing potential do not adopted adequate contraception methods;
  • Pregnant or nursing women;
  • Patients need to exclude in the opinion of investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157715

Locations
China, Fujian
Optometry and Ophthalmology Hospital of Wenzhou Medical College
Wenzhou, Fujian, China, 325027
China, Guangdong
Zhongshan Ophthalmic Center, Sun-Yat University
Guangzhou, Guangdong, China, 510060
China, Hunan
Second Affiliated Hospital of Xiangya Medical College
Changsha, Hunan, China, 410011
China, Shanxi
Xijing Hosiptal of the Fourth Military Medical University
Xian, Shanxi, China, 710032
China, Sichuan
Sichuan University West China Hospitcal
Chengdu, Sichuan, China, 610041
China
PekingTongren Hospital
Peking, China, 100730
Peking University People's Hospital
Peking, China, 100044
Shanghai First People's Hospital
Shanghai, China, 200080
Eye & ENT Hospital of Fudan University
Shanghai, China, 200031
Sponsors and Collaborators
Chengdu Kanghong Biotech Co.,Ltd.
Beijing DMS Pharma Ltd.
Digital Angiography Reading Center
Investigators
Principal Investigator: Xiaoxin Li, MD, Prof. Peking University People's Hospital
  More Information

No publications provided

Responsible Party: Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01157715     History of Changes
Other Study ID Numbers: KHSWKH902001
Study First Received: July 6, 2010
Last Updated: February 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chengdu Kanghong Biotech Co.,Ltd.:
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
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013