Neovascular Age Related Macular Degeneration MedDRA version: 20.1 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
Chengdu Kanghong Biotechnology Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men and women = 50 years of age at the Screening visit; 2.Females must be at least 1 year postmenopausal, or surgically sterilized, or, if of childbearing potential, must have a negative pregnancy test at the Screening visit; Women of childbearing potential must agree to use a highly effective method of contraception throughout the study (See complete list in the Study Procedures Manual); 3.Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and; 4.Have active subfoveal CNV lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal FA leakage, or definite subfoveal fluid by SD-OCT in the study eye at Screening; 5.Have CNV that is at least 50% of total lesion size in the study eye at Screening; 6.Have a ETDRS BCVA letter score of 78 to 25 (approximately 20/32 to 20/320 equivalent) in the study eye at Screening; 7.Have ocular media (lens, cornea, vitreous) of adequate clarity to permit high quality fundus imaging; 8.Are willing and able to sign the study written informed consent form (ICF). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: 1.Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD in the study eye except dietary supplements or vitamins; 2.Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit; 3.Have a total lesion size greater than twelve disc areas (30.5 mm2), including blood, fibrosis and neovascularization, as assessed by FA in the study eye at Screening; 4.Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is under the fovea and is one or more disc areas in size (greater than 2.5 mm2) in the study eye at Screening; 5.Have scarring or fibrosis making up greater than 50% of total lesion in the study eye at Screening; and/or scarring, fibrosis or atrophy involving the center of the fovea in the study eye at Screening; 6.Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline; 7.Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening; 8.Have any other cause of CNV, including pathologic myopia (defined per protocol as spherical equivalent of -8 diopters or more), ocular histoplasmosis syndrome, angioid streaks, inherited macular dystrophies, choroidal rupture, uveitis, punctate inner choroidopathy, or multifocal choroiditis in the study eye at Screening; 9.Have a history of or clinical evidence of significant diabetic retinopathy that could impact assessment of vision or affect central vision, diabetic macular edema, or any other vascular disease other than AMD including history or clinical evidence of retinal vein occlusion affecting the study eye at Screening; 10.Have had prior pars plana vitrectomy in the study eye; 11.Have presence of a full thickness macular hole at Screening or upon examination at Baseline or a history of a full thickness macular hole in the study eye; 12.Have a history of intraocular or periocular surgery within three months of Baseline in the study eye, except in the case of lid surgery, which may not have taken place within one month of Baseline as long as it is unlikely to interfere with IVT injection; 13.Have prior trabeculectomy or other filtration surgery in the study eye; 14.Have uncontrolled glaucoma (defined as intraocular pressure (IOP) greater than or equal to 22 mmHg at Baseline despite treatment with more than two anti-glaucoma medications) in the study eye; 15.Have active intraocular inflammation in either eye at Screening or upon examination at Baseline or a history of uveitis in either eye; 16.Have active ocular or periocular infection in either eye, or a history of any ocular or periocular infection within the two weeks prior to Screening in either eye; 17.Have presence or history of scleromalacia in either eye; 18.Have aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye; 19.Have had previous therapeutic radiation in the region of the study eye; 20.Have history of corneal transplant or presence of a corneal dystrophy that interferes with IOP measurements or imaging in the study eye; 21.Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study period;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this clinical study is to evaluate the efficacy and safety of 0.5 mg and 1.0 mg conbercept IVT injection compared with the vascular endothelial growth factor (VEGF) antagonist active control, aflibercept IVT injection (2.0 mg, Eylea®, Regeneron Pharmaceuticals, Inc.), in subjects with neovascular age-related macular degeneration (AMD). The primary objective is to determine if 0.5 mg or 1.0 mg conbercept is non-inferior to aflibercept 2.0 mg as measured by the change from baseline in best corrected visual acuity (BCVA) by Early Treatment of Diabetic Retinopathy Study (ETDRS) method at the Week 36 visit. The primary endpoint is the mean change from baseline in ETDRS BCVA letter score at Week 36 in the study eye. ;Secondary Objective: 1.To evaluate the difference in efficacy between conbercept doses and aflibercept, with respect to the following: •Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36; •Proportion of subjects gaining =15 ETDRS BCVA letters from baseline to Week 36; •Mean change from baseline in central retinal thickness (µm) by SD-OCT at Week 36; •Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48; •Mean change from baseline in ETDRS BCVA letter score at Week 96 2.To compare the safety and tolerability of conbercept doses and aflibercept, and to evaluate the pharmacokinetics and immunogenicity of conbercept doses, when feasible ;Primary end point(s): The primary objective is to determine if 0.5 mg or 1.0 mg conbercept is non-inferior to aflibercept 2.0 mg as measured by the change from baseline in best corrected visual acuity (BCVA) by Early Treatment of Diabetic Retinopathy Study (ETDRS) method at the Week 36 visit.;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is the mean change in ETDRS BCVA letter score from baseline at Week 36. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.To evaluate the difference in efficacy between conbercept doses and aflibercept, with respect to the following: •Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36; •Proportion of subjects gaining =15 ETDRS BCVA letters from baseline to Week 36; •Mean change from baseline in central retinal thickness (µm) by SD-OCT at Week 36; •Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48; •Mean change from baseline in ETDRS BCVA letter score at Week 96 2. To compare the safety and tolerability of conbercept doses and aflibercept, and to evaluate the pharmacokinetics and immunogenicity of conbercept doses, when feasible;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated at Week 36, Week 48 and Week 96, respectively | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Germany, Lithuania, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Singapore, Spain, Switzerland, Taiwan, United States
Contacts
Public ContactYan Cheng
Chengdu Kanghong Biotechnology Co., Ltd.
Outcome results
None listed