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

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
intravitreal injection of KH902
Sponsored by
Chengdu Kanghong Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring KH902, age-related macular degeneration (AMD), choroidal neovascularization (CNV), intravitreal injection, best corrected visual acuity (BCVA), central retinal thickness

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Optometry and Ophthalmology Hospital of Wenzhou Medical College
  • Zhongshan Ophthalmic Center, Sun-Yat University
  • Second Affiliated Hospital of Xiangya Medical College
  • Xijing Hosiptal of the Fourth Military Medical University
  • Sichuan University West China Hospitcal
  • Peking University People's Hospital
  • PekingTongren Hospital
  • Eye & ENT Hospital of Fudan University
  • Shanghai First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

0.5 mg cohort

2.0 mg cohort

Arm Description

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 .

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 .

Outcomes

Primary Outcome Measures

Change from baseline in BCVA
The incidence rate of adverse event

Secondary Outcome Measures

Change from baseline in central retinal thickness

Full Information

First Posted
July 6, 2010
Last Updated
November 5, 2014
Sponsor
Chengdu Kanghong Biotech Co., Ltd.
Collaborators
Beijing DMS Pharma Ltd., The Digital Angiography Reading Center (DARC)
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1. Study Identification

Unique Protocol Identification Number
NCT01157715
Brief Title
A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular AMD
Acronym
AURORA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Kanghong Biotech Co., Ltd.
Collaborators
Beijing DMS Pharma Ltd., The Digital Angiography Reading Center (DARC)

4. Oversight

5. Study Description

Brief Summary
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.
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.

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
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5 mg cohort
Arm Type
Experimental
Arm Description
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 .
Arm Title
2.0 mg cohort
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
intravitreal injection of KH902
Primary Outcome Measure Information:
Title
Change from baseline in BCVA
Time Frame
at 3-month
Title
The incidence rate of adverse event
Time Frame
at 3-month
Secondary Outcome Measure Information:
Title
Change from baseline in central retinal thickness
Time Frame
at 3-month and 12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoxin Li, MD, Prof.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry and Ophthalmology Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Fujian
ZIP/Postal Code
325027
Country
China
Facility Name
Zhongshan Ophthalmic Center, Sun-Yat University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Second Affiliated Hospital of Xiangya Medical College
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Xijing Hosiptal of the Fourth Military Medical University
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Sichuan University West China Hospitcal
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Peking University People's Hospital
City
Peking
ZIP/Postal Code
100044
Country
China
Facility Name
PekingTongren Hospital
City
Peking
ZIP/Postal Code
100730
Country
China
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
200031
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, Controlled Study of Intravitreal KH902 in Patients With Neovascular AMD

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