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

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)

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

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Biological: Intravitreal injection of KH902

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rate of adverse event	To evaluate the safety of multiple intravitreal injection of KH902 of each group.	at 52 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in BCVA	To evaluate the efficacy of multiple intravitreal injection of KH902 of each group in the mean change from baseline	Specified timepoints during the screening phase and 52-week treatment period

Collaborators and Investigators

• Sponsor: Chengdu Kanghong Biotech Co., Ltd.
• Collaborators: University of Wisconsin, Madison; Air Force Military Medical University, China
• Investigators: Principal Investigator: Junjun Zhang, West China Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: November 10, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: intravitreal injection; choroidal neovascularization; age-related macular degeneration; KH902; multiple injections
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Neovascularization, Pathologic; Macular Degeneration; Choroidal Neovascularization; Wet Macular Degeneration
• Other Study ID Numbers: KHSWKH902004