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

July 16, 2017 updated by: Chengdu Kanghong Biotech Co., Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Hospital
      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Zhaohui Li
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • xiaoxin Li
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Youxing Cheng
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Liu Yang
      • Beijing, China
        • Recruiting
        • Beijing Shijitan Hoospital.Cmu
        • Contact:
          • Lin Xiao
      • Beijing, China
        • Recruiting
        • Beijing Tongren Hospital,CMU
        • Contact:
          • Feng Zhang
      • Changsha, China
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Huizuo Xu
      • Changsha, China
        • Recruiting
        • The Scond Xiangya Hospital of Central South University
        • Contact:
          • Luosheng Tang
      • Guangzhou, China
        • Recruiting
        • General Hospial og Guangzhou Military Command of PLA
        • Contact:
          • Xiulan Zou
      • Guangzhou, China
        • Recruiting
        • Zhongshan Ophthalmic Center,Sun Yat-Sen University
        • Contact:
          • Chenjin Jin
      • Hainan, China
        • Recruiting
        • Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
          • Wangling Cheng
      • Hebei, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
      • Hebei, China
        • Recruiting
        • Hebei Eye Hospital
        • Contact:
          • Minlian Zhang
      • Henan, China
        • Recruiting
        • Henan Province People's Hospital
        • Contact:
          • Ke Fan
      • Jilin, China
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:
          • Guanfang Su
      • Lanzhou, China
        • Recruiting
        • Lanzhou University Second Hospital
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Qiong Zhou
      • Nanchang, China
        • Recruiting
        • Affiliated Eye Hospital of Nanchang University
        • Contact:
          • Jingling Yi
      • Nanjing, China
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
          • Qinghui Lui
      • Nanjing, China
        • Recruiting
        • Nanjing General Hospital
        • Contact:
          • Zhengping Huang
      • Ningxia, China
        • Recruiting
        • Ningxia Peple'S Hospital
        • Contact:
          • Shaoping Ha
      • Shanghai, China
        • Recruiting
        • Shanghai General Hospital
        • Contact:
          • Suqing Yu
      • Shanghai, China
        • Recruiting
        • Renji Hospital Shanghai Jiaotong University School of Medicine
        • Contact:
          • Lin Liu
      • Shanghai, China
        • Recruiting
        • Eye&ENT Hospital of Fudan University
        • Contact:
          • Yongjing Zhang
      • Shantou, China
        • Recruiting
        • Stu/Cuhk Joint Shantou International Eye Center
        • Contact:
          • Weiqi Cheng
      • Shanxi, China
        • Recruiting
        • Shanxi Eye Hospital
      • Shenzhen, China
        • Recruiting
        • Shenzhen Eye Hospital
        • Contact:
          • Qinshan Cheng
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Eye Hospital
      • Wenzhou, China
        • Recruiting
        • The Eye Hospital of Wmu Zhejiang Eye Hospital
      • Wuhan, China
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
          • Yiqiao Xing
      • Wulumuqi, China
        • Recruiting
        • The Chinese people's liberation army 474 hospital
        • Contact:
          • Yun Xiao
      • Xiamen, China
        • Recruiting
        • Xiamen Eye Centre of Xiamen University
        • Contact:
          • Guoji Wu
      • Zhejiang, China
        • Recruiting
        • the Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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;
  • 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;
  • Diabetics with uncontrolled blood glucose (fasting blood glucose ≥ 7.0 mmol/L or 2hPBG ≥ 11.1 mmol/L) and/or complicated with diabetic retinopathy;
  • Patient has had a surgical history one month before enrollment, and/or has unhealed wounds, ulcers and fractures at present;
  • Patient has infectious diseases required oral, intramuscular or intravenous administration at present;
  • Patient has a history of myocardial and/or cerebral infarction(s) within 6 months before screening, has received stenting and depends on such anticoagulants as warfarin and aspirin;
  • Patient chronically uses and cannot discontinue to use such anticoagulants as aspirin, clopidogrel and warfarin;
  • Patient has active and disseminated intravascular coagulation and distinct bleeding tendency three months before screening;
  • Hyperpietics with poor blood pressure control (defined as blood pressure remaining at ≥ 150/95 mmHg after antihypertensives therapy);
  • Patient is diagnosed with systemic immune disease (e.g., ankylosing spondylitis, systemic lupus erythematosus, and Behcet's disease) or has any uncontrollable clinical problem (e.g., AIDS, malignancies, active hepatitis, renal failure, severe mental, neurological, cardiovascular and respiratory diseases);
  • Patient has previously used drugs which may possibly cause renal toxicity, including chloroquine, hydroxychloroquine, phenothiazines, chlorpromazine, thioridazine, fluphenazine, perphenazine, and trifluoperazine;

  • Patient does not take effective contraceptive measures; Note: The following conditions are not included in the exclusion range.

    1. Amenorrhea for 12 months under the natural condition, or amenorrhea for 6 months under the natural condition and the serum FSH level of > 40 mIU/ml;
    2. Six weeks after bilateral ovariectomy with/without hysterectomy;

    3. Use of the following one or more acceptable contraceptions:

      • Sterilization (for males, with bilateral vasoligation and vasectomy)
      • Hormonal contraception (implantable, patchable, oral)
      • Intrauterine device and dural barrier method
    4. Ability to take reliable contraceptive measures over the study period and hold on to 30 days after study drug withdrawal (unacceptable contraceptive methods include: periodic continence - according to the calendar and ovulatory phase, body thermometry, post-ovulatory method, and coitus interruptus).
  • Pregnant women (in this trial pregnancy is defined as positive U-HCG) and breastfeeding mothers;
  • Patient has participated in any drug (not including vitamins and minerals) clinical trial three months before screening (if the study drug has a long half-life, i.e., its five half-lives exceed three months, then it is deemed as five half-lives); Those whom the reseacher deems necessary to exclude.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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;
Drug: Conbercept
Experimental: 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".
Drug: Conbercept

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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）.
Baseline, 12th and 48th week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Central Retinal Thickness (CRT)
Time Frame: week 48
To observe pre- and posttreatment changes in CRT on OCT
week 48
Change of Macular Retinal Thickness (MRT)
Time Frame: week 48
To observe pre-and posttreatment changes on OCT;
week 48
Volume and Thickness of Retinal Pigment Epithelial Detachment (PED)
Time Frame: week 48
To observe pre- and posttreatment changes in volume and thickness of PED on OCT;
week 48
Area and Regression of Polypoidal Lesion
Time Frame: week 48
To observe pre- and posttreatment changes in area and regression of polypoidal lesion on ICGA
week 48
Size of Retinal Hemorrhages
Time Frame: week 48
To observe pre- and posttreatment changes in size of retinal hemorrhages on CFP
week 48
Area of Branching Vascular Network
Time Frame: week 48
To observe pre- and posttreatment changes in area of BVN on ICGA
week 48
Frequency of Administration
Time Frame: up to 48 weeks
Refers to the average frequency of administration for both groups of subjects during the study.
up to 48 weeks
Incidence of adverse events (AEs) and reactions
Time Frame: up to 48 weeks
up to 48 weeks
Ophthalmic examination
Time Frame: up to 48 weeks
Ophthalmic examination include corneal、vitreous body、anterior chamber、iris、retina、disc、Macular 、drusen、PED examination Investigator will check whether the parts above is normal. Measurement for summarizing the data : Number of patients with different conditions of each part.
up to 48 weeks
General symptoms and vital signs
Time Frame: up to 48 weeks
Number of participants with abnormal symptoms or vital signs.
up to 48 weeks
Number of participants with adverse events as assessed by laboratory results
Time Frame: up to 48 weeks
Laboratory results include Blood routine 、Blood biochemistry、Coagulation function 、Urine routine 、Urinary pregnancy .
up to 48 weeks
Number of participants with treatment-related adverse events as assessed by other tests.
Time Frame: up to 48 weeks.
Other tests indicated that which is not contained in the study done by the participants .
up to 48 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chengdu Kanghong Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KH902-ST-CRP-2.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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