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

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ClinicalTrials.gov Identifier: NCT01242254
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : March 27, 2014
Sponsor:
Collaborators:
University of Wisconsin, Madison
Fourth Military Medical University
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co., Ltd.

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

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

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:

  1. 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;
  2. 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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : February 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The incidence rate of adverse event [ Time Frame: at 52 week ]
    To evaluate the safety of multiple intravitreal injection of KH902 of each group.


Secondary Outcome Measures :
  1. Change from Baseline in BCVA [ Time Frame: Specified timepoints during the screening phase and 52-week treatment period ]
    To evaluate the efficacy of multiple intravitreal injection of KH902 of each group in the mean change from baseline


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242254


Locations
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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
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Principal Investigator: Junjun Zhang West China Hospital
More Information
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Responsible Party: Chengdu Kanghong Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01242254     History of Changes
Other Study ID Numbers: KHSWKH902004
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: July 2011
Keywords provided by Chengdu Kanghong Biotech Co., Ltd.:
KH902
age-related macular degeneration
choroidal neovascularization
intravitreal injection
multiple injections
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes