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

NCT01157715 | Completed Phase 2

• 1 other identifier: KHSWKH902001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 9

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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

KH902; age-related macular degeneration (AMD); choroidal neovascularization (CNV); intravitreal injection; best corrected visual acuity (BCVA); central retinal thickness

Outcome Measures

Primary Outcomes (2)

• Change from baseline in BCVA

  at 3-month

• The incidence rate of adverse event

  at 3-month

Secondary Outcomes (1)

• Change from baseline in central retinal thickness

  at 3-month and 12-month

Study Arms (2)

0.5 mg cohort

EXPERIMENTAL

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

2.0 mg cohort

EXPERIMENTAL

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

Interventions

intravitreal injection of KH902 BIOLOGICAL

0.5 mg cohort; 2.0 mg cohort

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead
• Beijing DMS Pharma Ltd.: collaborator
• The Digital Angiography Reading Center (DARC): collaborator

Study Sites (9)

Optometry and Ophthalmology Hospital of Wenzhou Medical College

Wenzhou, Fujian, 325027, China

Location

Zhongshan Ophthalmic Center, Sun-Yat University

Guangzhou, Guangdong, 510060, China

Location

Second Affiliated Hospital of Xiangya Medical College

Changsha, Hunan, 410011, China

Location

Xijing Hosiptal of the Fourth Military Medical University

Xian, Shanxi, 710032, China

Location

Sichuan University West China Hospitcal

Chengdu, Sichuan, 610041, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

PekingTongren Hospital

Beijing, 100730, China

Location

Eye & ENT Hospital of Fudan University

Shanghai, 200031, China

Location

Shanghai First People's Hospital

Shanghai, 200080, China

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoxin Li, MD, Prof.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 7, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

CN (9)