A Phase 3 Clinical Trial of Intravitreal Injections of Human Recombinant Vascular Endothelial Growth Factor Receptor-Fc Fusion Protein in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

KHSWKH902005

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.

2011-08-01

2012-12-01

2013-11-01

Completed

Early phase I

125

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Patients of child-bearing potential do not adopted adequate contraception methods; * Pregnant or nursing women; * Patients should be excluded in the opinion of investigators;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 125, 'type': 'ACTUAL'}}

2023-04-18