The Efficacy Assessment of Intravitreal Injection of Conbercept in Patients With Polypoidal Choroidal Vasculopathy (PCV)

Chengdu Kanghong Biotech Co., Ltd.35 sites in 1 country300 target enrollmentOctober 2015

ConditionsPolypoidal Choroidal Vasculopathy (PCV)

InterventionsConbercept

DrugsConbercept

Overview

Phase: Phase 4
Intervention: Conbercept
Conditions: Polypoidal Choroidal Vasculopathy (PCV)
Sponsor: Chengdu Kanghong Biotech Co., Ltd.
Enrollment: 300
Locations: 35
Primary Endpoint: Change of Best Corrected Visual Acuity
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the efficacy of intravitreal injection of 0.5 mg conbercept in patients with polypoidal choroidal vasculopathy (PCV) and explore the optimal route of administration.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

December 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient who has signed an informed consent form and is inclined to be followed up within the time stipulated in the trial;
•Patient with wet AMD aged ≥ 45, of either sex;
•The eye of interest must meet the following requirements:
•BCVA is at least 19 and at most 83 alphabets (equivalent to a visual acuity of 20/25 to 20/400 for the Snellen Eye Chart);
•Patient has been diagnosed with active PCV on ICGA (confirmed by the third-party radiodiagnosis center); The diagnostic criteria for "active" PCV on ICGA are as follows: image indicates polypoid lesions as typical nodular high fluorescein area (observed stereoscopically) and also depicts one of the following angiographic findings: 1) nodular lesions surrounded by the weak halo; 2) nodular lesions nourished by abnormal vascular beds; and 3) nodular pulsation on dynamic ICGA;
•In case of the eye of interest complicated with subretinal hemorrhage or hemorrhage under the pigment epithelium, the range of hemorrhage should not be beyond the upper and lower vascular arcades in the macular area, and the total thickness of the central fovea (i.e., the thickness between the apex of the central fovea and the choriocapillary layer) is no more than 600 µm;
•Neither ocular media opacity nor miosis is noted to influence the fundus examination.
•Subject with the BCVA of no less than 19 alphabets for his/her eye of non-interest (equivalent to a visual acuity of 20/400 for the Snellen Eye Chart).
•Note: Each subject in the study can include only one eye of interest; the eye of interest is determined by the researcher from a medical point of view if both eyes of the subject meet the inclusion criteria.

Exclusion Criteria

•Subfoveal fibrous tissues are present in the eye of interest on CFP and OCT;
•Researcher judges that existing or previous ocular diseases in the eye of interest influence the macular detection or the central visual acuity (CNV secondary to diseases other than AMD, diabetic retinopathy, uveitis, angioid streaks, pathologic myopia, retinal pigment epithelium (RPE) tears, macular holes, any retinal vasculopathy, vein occlusion, amblyopia, retinal inflammatory diseases, central serous choroidopathy, previous or existing retinal detachment, macular edema, anterior ischemic optic neuropathy, pseudovitelliform macular degeneration, vitreomacular traction syndrome, rhegmatogenous retinal detachment, generalized choroidal atrophy, and optic atrophy (pale));
•There is any history of vitreous hemorrhage three months before screening;
•The eye of interest has received any drug therapy for AMD (e.g., pegaptanib sodium or steroids) or any anti-VEGF therapy (e.g., ranibizumab or bevacizumab);
•The eye of interest has received verteporfin-photodynamic therapy (PDT) and foveal laser-induced thermal therapy (including subfoveal or paracentral photocoagulation, grid photocoagulation, transpupillary thermotherapy (TTT) and pan-retinal photocoagulation);
•The eye of interest has received intra- or periocular surgery (including parafoveal laser photocoagulation treatment, cataract surgery, and YAG laser posterior capsulotomy) within three months, except eyelid surgery having no effect on intravitreal injection (but eyelid surgery could not be performed one month before medication);
•The eye of interest has received the following ophthalmic operations, including vitrectomy, macular translocation, glaucoma surgery, laser photocoagulation and pan-retinal photocoagulation, as well as other submacular surgeries or other surgeries for CNV;
•The eye of interest has received keratoplasty;
•Either eye has active eye infection (e.g., blepharitis, infective conjunctivitis, keratitis, scleritis, and endophthalmitis) or recurrent infection, or the eye of interest has been infected 30 days before screening;
•Patient has either previous or existing uncontrollable glaucoma (defined as IOP remaining at above 25 mmHg after anti-glaucoma treatment), or the cup-to-disc ratio of the eye of interest is above 0.8 due to severe glaucoma, or the eye of interest has received glaucoma filtration surgery;

Arms & Interventions

3+Q12W

The eye of interest will first receive three consecutive intravitreal injections of 0.5 mg conbercept every 4 weeks, followed by every 12 weeks. If the subject meets the "additional medication criteria" in 12 weeks during treatment, additional injection can be given;

Intervention: Conbercept

3+TAE

The eye of interest will first receive three consecutive intravitreal injections of 0.5 mg conbercept every 4 weeks, then the researcher will determine the next follow-up visit time/treatment interval based on results of each follow-up assessment as per the "treatment-extended dosing criteria". When the follow-up/treatment interval of the subject is extended to 12 weeks, additional safety follow-up visit can be arranged if any suspicious active lesion is deemed by the researcher; additional injection can be given if the result of safety follow-up assessment meets the "extra dosing criteria".

Intervention: Conbercept

Outcomes

Primary Outcomes

Change of Best Corrected Visual Acuity

Time Frame: Baseline, 12th and 48th week

The investigators will use the ETARS Chart which is international standard to measure the vision ability of participants.Best corrected visual is the number of letters which the participants can read on the ETARS Chart ,all procedure should be done according to SOP.The BCVA of 12th week and 48th week will be compared with the base line（pre-treatment）.

Secondary Outcomes

Incidence of adverse events (AEs) and reactions(up to 48 weeks)
Central Retinal Thickness (CRT)(week 48)
Change of Macular Retinal Thickness (MRT)(week 48)
Volume and Thickness of Retinal Pigment Epithelial Detachment (PED)(week 48)
Area and Regression of Polypoidal Lesion(week 48)
Size of Retinal Hemorrhages(week 48)
Area of Branching Vascular Network(week 48)
Frequency of Administration(up to 48 weeks)
Ophthalmic examination(up to 48 weeks)
General symptoms and vital signs(up to 48 weeks)
Number of participants with adverse events as assessed by laboratory results(up to 48 weeks)
Number of participants with treatment-related adverse events as assessed by other tests.(up to 48 weeks.)