A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD

NCT01436864 | Completed Phase 3

• 1 other identifier: KHSWKH902005
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 11

Brief Summary

This study is designed to prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902); age-related macular degeneration (AMD); choroidal neovascularization (CNV); intravitreal injection; best corrected visual acuity (BCVA); central retinal thickness

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in BCVA

  To evaluate the mean change from baseline in best-corrected visual acuity (BCVA) in KH902 treatment group and sham treatment group at month 3 and compare the difference between the values

  at month 3

Secondary Outcomes (2)

• The incidence rate of adverse event

  at month 3

• Mean change of retinal thickness from baseline

  at month 3

Study Arms (2)

0.5 mg KH902

EXPERIMENTAL

Patients will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, and then patients will receive 2 sham injections monthly, respectively, at the end of month 3 (visit 5), and following these injections you will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 5, month 8 and month 11)

Biological: Recombinant Human VEGF Receptor-Fc Fusion Protein

Sham-injection

SHAM COMPARATOR

Patients will receive sham injection once per month for three times, and then you will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, after three months' treatment they will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 8 and month 11.

Biological: Recombinant Human VEGF Receptor-Fc Fusion Protein

Interventions

Recombinant Human VEGF Receptor-Fc Fusion Protein BIOLOGICAL

Intravitreal injection of KH902 once per month

0.5 mg KH902; Sham-injection

Eligibility Criteria

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

You may qualify if:

• Signed the Informed Consent Form;
• Age ≥ 50 years of either gender;
• Total lesion size ≤ 30 mm2 of the study eye;
• BCVA score of the study eye between 73 and 19 letters;
• Clear ocular media and adequate pupil dilation to permit good quality fundus photographic imaging.
• BCVA score of the fellow eye ≥ 19 letters.

You may not qualify if:

• Current or previous non-exudative AMD diseases which affect the inspection and measurement of macular or the central visual acuity;
• Subretinal hemorrhage area≥ 50% of total lesion size;
• Scar or fibrosis area in study eyes ≥ 50% of total lesion size; or central foveal scar、fibrosis or atrophy of macular in the study eye;
• Presence of retinal pigment epithelial tear, retinal macular tractional, macular epiretinal membrane, and diagnosed with polypoidal choroidal vasculopathy in the study eye;
• Previous anti-VEGF drug treatment in the study eye within six months preceding screening; or anti-VEGF treatment in the fellow eye within three months before screening;
• Previous intraocular or periocular operations, excluding operations on eyelid without hampering the intravitreal injection in the study eye;
• Previous ophthalmologic operations in the study eye;
• Current active inflammation or infection in either eye;
• Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
• Current systemic administrations which may lead to toxicity in the crystalline lens;
• History of allergy or current allergic response;
• History of surgery within one month preceding enrollment;
• Infectious diseases need systemic administration;
• Systemic autoimmune diseases;
• Any uncontrolled clinical disorders;

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead
• University of Wisconsin, Madison: collaborator

Study Sites (11)

First Affiliated Hospital of Fujian Medical College

Fuzhou, Fujian, 350005, China

Location

Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, Guangdong, 515041, China

Location

People's Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Wuhan General Hospital of Guangzhou Military Command

Wuhan, Hubei, 430070, China

Location

Wuxi Second People's Hospital

Wuxi, Jiangsu, 214002, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Ophthalmologic Hospital of Qingdao

Qingdao, Shandong, 266071, China

Location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

Daping Hospital of the Third Military Medical University

Chongqing, 400042, 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

• Xun Xu

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 19, 2011
• First Posted: September 20, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: November 1, 2013
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (11)