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The Efficacy Assessment of Intravitreal Injection of Conbercept in Patients With Polypoidal Choroidal Vasculopathy (PCV) | Clinical Trials | Clareo Health

UNKNOWNPHASE4

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

NCT03159884•Chengdu Kanghong Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

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:
•1. 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);
•2. 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;
•3. 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;
•4. 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).

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;
+24 more criteria

Locations (35)

Beijing Hospital

Beijing, China

Beijing Shijitan Hoospital.Cmu

Beijing, China

Beijing Tongren Hospital,Cmu

Beijing, China

Chinese Pla General Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Peking University First Hospital

Beijing, China

Peking University People'S Hospital

Beijing, China

PEKING UNIVERSITY Third HOSPITAL

Beijing, China

The Scond Xiangya Hospital of Central South University

Changsha, China

Xiangya Hospital Central South University

Changsha, China

Key Dates

Start Date

October 1, 2015

Primary Completion Date

June 1, 2018

Completion Date

December 1, 2018

Last Updated

July 19, 2017

Enrollment

300

ESTIMATED participants

Conditions

Polypoidal Choroidal Vasculopathy (PCV)

Interventions

Conbercept

DRUG

Contacts

xiaoxin Li

CONTACT

dr_lixiaoxin@163.com

A Prospective, Multicenter, Open-label, Randomized Clinical Trial to Evaluate the Efficacy, Durability, and Safety of Aflibercept 8mg in Different Treatment Regimens in Chinese Patients With Polypoidal Choroidal Vasculopathy (PCV)

NCT07365371

Polypoidal Choroidal Vasculopathy (PCV)Neovascular Age Related Macular Degeneration (AMD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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