Clinical trial NCT01242254: A Study Assessing the Safety and Efficacy of Multiple Intravitreal KH902 in Patients With CNV Due to AMD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: KH902
age-related macular degeneration
choroidal neovascularization
intravitreal injection
multiple injections
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Wisconsin, Madison
name: Air Force Military Medical University, China
First posted: 2010-11-16
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: The incidence rate of adverse event
timeFrame: at 52 week
Secondary outcomes:
measure: Change from Baseline in BCVA
timeFrame: Specified timepoints during the screening phase and 52-week treatment period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital ,Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Junjun Zhang
role: PRINCIPAL_INVESTIGATOR
References: