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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.
The Digital Angiography Reading Center (DARC)
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01157715
First received: July 6, 2010
Last updated: November 5, 2014
Last verified: November 2014

July 6, 2010
November 5, 2014
May 2010
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • best-corrected visual acuity(BCVA) [ Time Frame: BCVA will be assessed over a 3-month treatment period and a 12-month treatment period ] [ Designated as safety issue: No ]
    To evaluate the efficacy of intravitreal injection of KH902 of each group in the mean change from baseline in best-corrected visual acuity (BCVA) over a 3-month treatment period and a 12-month treatment period.
  • the change of physical symptoms and signs, the results of lab and other examinations, and incidence rate of adverse event and adverse reaction [ Time Frame: over a 12-month treatment period ] [ Designated as safety issue: Yes ]
    To evaluate the safety of intravitreal injection of KH902 of each group by the change of physical symptoms and signs, the results of lab and other examinations, and incidence rate of adverse event and adverse reaction over a 12-month treatment period.
Complete list of historical versions of study NCT01157715 on ClinicalTrials.gov Archive Site
Change from baseline in central retinal thickness [ Time Frame: at 3-month and 12-month ] [ Designated as safety issue: No ]
central retinal thickness [ Time Frame: over a 3-month treatment period and a 12-month treatment period ] [ Designated as safety issue: No ]
To evaluate the effects of intravitreal injection of KH902 on central retinal thickness and other anatomical changes by optical coherence tomography (OCT), color fundus photography, indocyanine green angiography (ICGA), and fluorescein fundus angiography (FFA) over a 3-month and 12-month treatment
Not Provided
Not Provided
 
A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular AMD
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)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neovascular Age-related Macular Degeneration
Biological: intravitreal injection of KH902
  • 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 .
    Intervention: 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 .
    Intervention: Biological: intravitreal injection of KH902
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
July 2012
January 2012   (final data collection date for primary outcome measure)

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 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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01157715
KHSWKH902001
Not Provided
Chengdu Kanghong Biotech Co.,Ltd.
Chengdu Kanghong Biotech Co.,Ltd.
  • Beijing DMS Pharma Ltd.
  • The Digital Angiography Reading Center (DARC)
Principal Investigator: Xiaoxin Li, MD, Prof. Peking University People's Hospital
Chengdu Kanghong Biotech Co.,Ltd.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP