Polypoidal Choroidal Vasculopathy (PCV)Phase 4STARNCT03159884

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

A Phase 4 study testing Conbercept in people with Polypoidal Choroidal Vasculopathy (PCV), run by Chengdu Kanghong Biotech Co., Ltd. at 35 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Polypoidal Choroidal Vasculopathy (PCV)
What is being tested?: Conbercept
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 35 sitesChina
Study dates: Oct 2015to Dec 2018
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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);

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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.
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;
Six weeks after bilateral ovariectomy with/without hysterectomy;
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
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.

Trial locations and contacts

35 sites in 1 country.

xiaoxin Li contact

dr_lixiaoxin@163.com

City, postcode or hospital

Sites recruiting now only

35 sites in 1 country

China35 sites, 35 recruiting

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

Other trials in China

About this study

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.

Conditions: Polypoidal Choroidal Vasculopathy (PCV)
Being tested: Conbercept
Medical subject headings: Polypoidal Choroidal Vasculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ConberceptDrug

Study groups in NCT03159884
Study group	Role	What they receive
3+Q12W	Experimental	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; Receives: Drug: Conbercept
3+TAE	Experimental	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". Receives: Drug: Conbercept

What is being measured

The primary outcome is the main question the study is designed to answer.

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）.
Measured: Baseline, 12th and 48th week

Secondary outcomes (12)

Central Retinal Thickness (CRT)
To observe pre- and posttreatment changes in CRT on OCT
Measured: week 48
Change of Macular Retinal Thickness (MRT)
To observe pre-and posttreatment changes on OCT;
Measured: week 48
Volume and Thickness of Retinal Pigment Epithelial Detachment (PED)
To observe pre- and posttreatment changes in volume and thickness of PED on OCT;
Measured: week 48
Area and Regression of Polypoidal Lesion
To observe pre- and posttreatment changes in area and regression of polypoidal lesion on ICGA
Measured: week 48
Size of Retinal Hemorrhages
To observe pre- and posttreatment changes in size of retinal hemorrhages on CFP
Measured: week 48
Area of Branching Vascular Network
To observe pre- and posttreatment changes in area of BVN on ICGA
Measured: week 48
Frequency of Administration
Refers to the average frequency of administration for both groups of subjects during the study.
Measured: up to 48 weeks
Incidence of adverse events (AEs) and reactions
Measured: up to 48 weeks
Ophthalmic examination
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.
Measured: up to 48 weeks
General symptoms and vital signs
Number of participants with abnormal symptoms or vital signs.
Measured: up to 48 weeks
Number of participants with adverse events as assessed by laboratory results
Laboratory results include Blood routine 、Blood biochemistry、Coagulation function 、Urine routine 、Urinary pregnancy .
Measured: up to 48 weeks
Number of participants with treatment-related adverse events as assessed by other tests.
Other tests indicated that which is not contained in the study done by the participants .
Measured: up to 48 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Dec 2018

First posted19 May 2017
Study startOct 2015
Primary completionJun 2018 (estimated)
Study completionDec 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Polypoidal Choroidal Vasculopathy (PCV)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03159884
Sponsor's protocol ID: KH902-ST-CRP-2.0
Acronym: STAR
Status last verified: Feb 2017
First submitted: 8 Feb 2017
Last updated: 19 Jul 2017
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy Assessment of Intravitreal Injection of Conbercept in Patients With Polypoidal Choroidal Vasculopathy (PCV)
ClinicalTrials.gov ID: NCT03159884
Acronym / sponsor ID: STAR / KH902-ST-CRP-2.0
Conditions: Polypoidal Choroidal Vasculopathy (PCV)
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 300 participants (estimated)
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Jun 2018 (estimated)
Study completion: Dec 2018 (estimated)
First posted: 19 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
3+Q12W	Experimental	Drug: ConberceptThe 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	Experimental	Drug: ConberceptThe 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".

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:
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.

Key exclusion criteria (34 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Conbercept	Drug	3+Q12W, 3+TAE

Primary outcome

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）.

12 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

xiaoxin Li contact

dr_lixiaoxin@163.com

35 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Conbercept in people with Polypoidal Choroidal Vasculopathy (PCV), run by Chengdu Kanghong Biotech Co., Ltd. at 35 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact xiaoxin Li (dr_lixiaoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Best Corrected Visual Acuity (time frame: Baseline, 12th and 48th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03159884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.