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

Sponsor

Chengdu Kanghong Biotech Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01157715

Collaborator

Beijing DMS Pharma Ltd. (Other), The Digital Angiography Reading Center (DARC) (Other)

122

Enrollment

Locations

Arms

Duration (Months)

13.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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)

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change from baseline in BCVA [at 3-month]
The incidence rate of adverse event [at 3-month]

Secondary Outcome Measures

Change from baseline in central retinal thickness [at 3-month and 12-month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optometry and Ophthalmology Hospital of Wenzhou Medical College	Wenzhou	Fujian	China	325027
2	Zhongshan Ophthalmic Center, Sun-Yat University	Guangzhou	Guangdong	China	510060
3	Second Affiliated Hospital of Xiangya Medical College	Changsha	Hunan	China	410011
4	Xijing Hosiptal of the Fourth Military Medical University	Xian	Shanxi	China	710032
5	Sichuan University West China Hospitcal	Chengdu	Sichuan	China	610041
6	Peking University People's Hospital	Peking		China	100044
7	PekingTongren Hospital	Peking		China	100730
8	Eye & ENT Hospital of Fudan University	Shanghai		China	200031
9	Shanghai First People's Hospital	Shanghai		China	200080