The Efficacy Assessment of Intravitreal Injection of Conbercept in Patients With Polypoidal Choroidal Vasculopathy (PCV)
STAR
1 other identifier
interventional
300
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2015
Typical duration for phase_4
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 19, 2017
February 1, 2017
2.7 years
February 8, 2017
July 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Best Corrected Visual Acuity
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）.
Baseline, 12th and 48th week
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
3+Q12W
EXPERIMENTALThe 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;
3+TAE
EXPERIMENTALThe 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".
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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;
- No ruptured lens (excluding pseudophakic) or posterior lens capsule (except YAG laser posterior capsulotomy after intraocular lens implantation);
- Patient needs to receive cataract surgery three months after enrollment (i.e., the researcher judges that BCVA may decrease by no less than 10 alphabets for the subject if the surgery is not performed);
- The eye of interest has ocular tumor;
- There is a history of systemic use of anti-VEGF agent(s) in six months;
- Patient has a history of anaphylaxis and allergy to fluorescein sodium and indocyanine green, and of allergy to protein products for diagnosis or treatment, and is allergic to no less than two drugs and/or non-drug factors, or suffers from allergic diseases now;
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
General Hospial og Guangzhou Military Command of PLA
Guangzhou, China
ZhongShan Ophthalmic Center,Sun Yat-sen University
Guangzhou, China
Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University
Hainan, China
Hebei Eye Hospital
Hebei, China
The Second Hospital of Hebei Medical University
Hebei, China
Henan Province People's Hospital
Henan, China
The Second Hospital of Jilin University
Jilin, China
Lanzhou University Second Hospital
Lanzhou, China
Affiliated Eye Hospital of Nanchang University
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing General Hospital
Nanjing, China
The First Affiliated Hospital With Nanjing Medical University
Nanjing, China
Ningxia Peple'S Hospital
Ningxia, China
Eye&Ent Hospital of Fudan University
Shanghai, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
Shanghai General Hospital
Shanghai, China
Stu/Cuhk Joint Shantou International Eye Center
Shantou, China
Shanxi Eye Hospital
Shanxi, China
Shenzhen Eye Hospital
Shenzhen, China
Tianjin Medical University Eye Hospital
Tianjin, China
The Chinese people's liberation army 474 hospital
Ürümqi, China
The Eye Hospital of Wmu Zhejiang Eye Hospital
Wenzhou, China
Renmin Hospital of Wuhan University
Wuhan, China
Xiamen Eye Centre of Xiamen University
Xiamen, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2017
First Posted
May 19, 2017
Study Start
October 1, 2015
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
July 19, 2017
Record last verified: 2017-02