Submitted by: John Michael Dominic Go 2018-11-19 00:00:00 Last Updated by: Jeverly Ann S. Principe 2018-12-05 15:52:49 Export to PDF

A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age-related Macular Degeneration

PHRR181205-001985

KHB-1801

2018-CT0455

A Multicenter, Double-masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age-related Macular Degeneration

This is a multicenter, double-masked, randomized, dose-ranging trial evaluate the efficacy and safety Conbercept IVT injection compared with aflibercept IVT injection in subjects with neovascular age-related macular degeneration (AMD).

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2019-01-01 42 2022-07-01 0000-00-00

Pending

Sites are yet to be initiated

Institution Classification Region LTO #
Chengdu Kanghong Biotechnology Co., Ltd. Private Business China N/A
Institution Classification Region LTO #
INC Research Pte. Ltd. Private Business NCR CDRR-NCR-CRO-1
Institution Amount Region
Chengdu Kanghong Biotechnology Co., Ltd. N/A China
Name E-Mail Phone Number Postal Address
KH916 Project Office panda@cnkh.com +86 (028) 83198965 36 Shuxi Road, Jinniu District, Chengdu, China
Name E-Mail Phone Number Postal Address
Yan Cheng, Chief Medical Officer, MD, PhD chengyan@cnkh.com +1 862 781 6160 100 Enterprise Drive, Suite 301, Rockaway, NJ 07866 USA
Name Expertise Affiliation
Harvey Uy, MD Ophthalmology Peregrine Eye and Laser Institute
Marie Joan Loy, MD Ophthalmology St. Luke's Medical Center - Quezon City
Sherman Valero, MD Ophthalmology The Medical City
Project Location Institutional Ethics Review Board
Peregrine Eye and Laser Institute Peregrine Eye and Laser Institute Institutional Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Committee
The Medical City The Medical City - Institutional Review Board

Neovascular Age-related Macular Degeneration

The primary endpoint is the mean change from baseline in ETDRS BCVA letter score at Week 36 in the study eye.

Secondary outcomes are based on the following:

 

- Proportion of subjects maintaining vision (i.e., losing

- 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

Pending

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • Germany
  • Lithuania
  • Netherlands
  • New Zealand
  • Philippines
  • Poland
  • Portugal
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United States

Clinical Trial

20180716081334

2018-10-17

None

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
 
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).
 
 
 
 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;
 
22.  Have any concurrent ocular condition in the study eye that, in the opinion of the Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or that otherwise may interfere with the injection procedure or with evaluation of efficacy or safety during the study;
 
23.  Have any evidence by medical history, physical examination or clinical laboratory testing at Screening or Baseline that shows reasonable suspicion of a disease or condition that contraindicates the use of study medication (conbercept or aflibercept) or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications;
 
24.  Have any use of long acting intraocular steroids, including implants, within six months prior to Day 1, Baseline;
 
25.  Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography;
 
26.  Any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control;
 
27.  If female, be pregnant (positive urine pregnancy test at Screening) or breastfeeding

Interventional

Conbercept for intravitreal injection

Conbercept, a biologic that functions as a VEGF-antagonist, is being developed for the treatment of VEGF-associated CNV originating from AMD.
 
 
Conbercept for intravitreal injection is supplied in single-use vials containing a sterile, preservative-free aqueous solution for IVT injection.

Randomized

Double Blind

Unspecified

Parallel

The study will randomize approximately 1140 subjects in a ratio of 1:1:1

Phase III

30

Unspecified

Unspecified

01 Jan 2019

Utilization Utilization Info
No records found.

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