A Study Assessing the Safety and Efficacy of Multiple Intravitreal KH902 in Patients With CNV Due to AMD - Full Text View

Purpose

This study is designed to assess the efficacy and safety of multiple intravitreal injection of KH902 in patients with CNV due to AMD.

Condition	Intervention	Phase
Neovascular Age-related Macular Degeneration	Biological: Intravitreal injection of KH902	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label, Multicenter, Randomized, Uncontrolled Study Assessing the Safety and Efficacy of KH902 in Patients With Choroidal Neovascularization Due to Neovascular Age-related Macular Degeneration(HOPE Study)

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Macular Degeneration

Genetic and Rare Diseases Information Center resources: Uveal Diseases

U.S. FDA Resources

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

Primary Outcome Measures:

The incidence rate of adverse event [ Time Frame: at 52 week ] [ Designated as safety issue: Yes ]
To evaluate the safety of multiple intravitreal injection of KH902 of each group.

Secondary Outcome Measures:

Change from Baseline in BCVA [ Time Frame: Specified timepoints during the screening phase and 52-week treatment period ] [ Designated as safety issue: No ]
To evaluate the efficacy of multiple intravitreal injection of KH902 of each group in the mean change from baseline


Enrollment:	36
Study Start Date:	August 2009
Study Completion Date:	February 2011
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Patients will receive an intravitreal injection of KH902 0.5mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52	Biological: Intravitreal injection of KH902 0.5 mg 2.0 mg once per 4 weeks during fixed dosing phase once as needed during extended treatment phase
Experimental: Group B Patients will receive an intravitreal injection of KH902 2.0mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52	Biological: Intravitreal injection of KH902 0.5 mg 2.0 mg once per 4 weeks during fixed dosing phase once as needed during extended treatment phase

Detailed Description:

Due to conclusions of KH902 Ia study:

Doses of single intravitreal injection of a recombinant human VEGF receptor-Fc fusion protein (KH902) in patients with CNV secondary to neovascular AMD are from 0.05 mg to 3.0 mg. The trial shows that KH902 is safe and tolerable, and no DLT, ophthalmia reaction, endophthalmitis, or systemic AE relevant to the drug is reported, and the main AEs are transient ocular tension increase and micro-hemorrhage in injection site. KH902 appears to produce rapid clinical effects on VA, supported by improvements in anatomical features, in patients with neovascular AMD.

HOPE Study is an open label, multi-center, randomized, uncontrolled dose-and interval-ranging phase Ib study designed to assess the efficacy and safety of multiple intravitreal injection of KH902 at variable dosing regimen in patients with CNV due to AMD. Two groups of patients will initially receive intravitreal administration of KH902 following the randomization:

Patients in group A will receive monthly intravitreal injections of KH902 for 3 times successively at a dose of 0.5 mg/50 μl/eye;
Patients in group B will receive monthly intravitreal injections of KH902 for 3 times successively at a dose of 2.0 mg/50 μl/eye.

Following the initial 12-week fixed-dosing phase of the trial:

Patients in group A and group B will continue to receive monthly intravitreal injections of KH902 with 0.5 mg/50 μl/eye or 2.0 mg/50 μl/eye as same as the doses he/she received during the fixed dosing phase, on an as needed (PRN) dosing schedule, based upon the need for re-treatment in accordance with pre-specified criteria up till week 52.

Eligibility


Ages Eligible for Study:	45 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed the Informed Consent Form by patients or legal representative;
Men and women ≥ 45 years of age;
Active primary or recurrent lesions with CNV secondary to neovascular AMD;
Total lesion size ≤ 12 disc areas in either eye;
BCVA of the study eyes ＜ 69 letters and the BCVA of fellow eyes ≥ 19 letters;
Clear ocular media and adequate pupil dilation.

Exclusion Criteria:

CNV lesion secondary to ocular conditions other than neovascular AMD
History of vitreous hemorrhage, retinal tear, rhegmatogenous retinal detachment or macular hole in the study eye;
Presence of retinal detachment, retinal pigment epithelial tear, or retinal macular traction in the study eye;
Anaphylactic disease;
Uncontrolled glaucoma in either eye;
Current active ocular inflammation or infection in either eye;
Previous anti-VEGF drug treatment in the study eye within three months preceding screening, and/or, for the fellow eye, within one month preceding screening;
Previous ophthalmologic operation or laser therapy in the study eye within three months preceding screening;
Current non-healing wound, ulcer, fractures, etc;
Uncontrolled systemic conditions;
Patients of child-bearing potential do not adopted adequate contraception methods;
Pregnant or nursing women.

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: NCT01242254

Locations


China, Beijing
Beijing Tongren Hospital
Beijing, Beijing, China, 100000
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200000
China, Sichuan
West China Hospital ,Sichuan University
Chengdu, Sichuan, China, 610000

Sponsors and Collaborators

Chengdu Kanghong Biotech Co.,Ltd.

University of Wisconsin, Madison

Fourth Military Medical University

Investigators


Principal Investigator:	Junjun Zhang	West China Hospital

More Information


Responsible Party:	Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT01242254 History of Changes
Other Study ID Numbers:	KHSWKH902004
Study First Received:	November 10, 2010
Last Updated:	March 25, 2014
Health Authority:	China: Food and Drug Administration

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


KH902 age-related macular degeneration choroidal neovascularization intravitreal injection multiple injections

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 23, 2016

A Study Assessing the Safety and Efficacy of Multiple Intravitreal KH902 in Patients With CNV Due to AMD (HOPE)