Intraocular injection conbercept is safe and effective to improve vision, relieve symptoms for patients suffered from choroidal neovascularization secondary to punctate inner choroidopathy

ISRCTN	ISRCTN85678307
DOI	https://doi.org/10.1186/ISRCTN85678307
Protocol serial number	20150501
Sponsor	Zhongshan Ophthalmic Center
Funders	National Natural Science Foundation of China (grant number 81570831, 81470647) , the Fundamental Research Funds of State Key Laboratory of Ophthalmology

Submission date: 08/05/2017
Registration date: 11/05/2017
Last edited: 31/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Punctate inner choroidopathy (PIC) is eye disease that affects the choroid (connective tissue layer of the eye) and the retina (the part of the eye where light signals are sent to the brain to create an image). It often occurs in young women and can lead to vision loss. It causes small, yellow lesions, usually at the back of the eye. Symptoms of PIC include blurred vision, photopsia (flashes of lights), and scotomata (blind spots). The majority cases of PIC are usually have good visual prognosis (outcomes). However, choroidal neovascularization (CNV) can develop secondary to PIC leading to blindness. CNV creates a layer of new blood vessels in the choroid layer of the eye which can damage vision. The treatment for CNV is to take anti-vascular endothelial growth factor medications (to control and reduce formation of new blood vessels). Conbercept has recently been approved China as a medication that can be used to treat CNV. The aim of this study is to see whether intravitreal injection (an injection into the eye) of conbercept is a safe and effective way to improve vision and anatomical outcomes in patients with CNV and PIC.

Who can participate?
Adults aged 18 and older who have CNV.

What does the study involve?
Participants receive a single injection of conbercept. If they have swelling, extra fluid or leakage found in the eyes they are re-injected with the medication. Participants attend monthly follow up appointments for six months. Participants are assessed for their vision, leakage, and fluid buildup to see if there has been any improvement to their CNV/PIC symptoms. The researchers collect this information by reviewing medical records in order to see how effective and safe this treatment is.

What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.

Where is the study run from?
Zhongshan Ophthalmic Center (China)

When is the study starting and how long is it expected to run for?
March 2015 to November 2016

Who is funding the study?
1. National Natural Science Foundation of China (China)
2. Fundamental Research Funds of State Key Laboratory of Ophthalmology (China)

Who is the main contact?
Professor Feng Wen

Contact information

Prof Feng Wen
Scientific

State Key Laboratory of Ophthalmology
Zhongshan Ophthalmic Center
Sun Yat-sen University
54 South Xianlie Road
Guangzhou
510060
China

ORCID ID	0000-0003-3319-4051

Study information

Primary study design	Observational
Study design	Retrospective single-center consecutive interventional non-comparative case series
Secondary study design	Case series
Study type	Participant information sheet
Scientific title	Efficacy and safety of conbercept as a primary treatment for choroidal neovascularization secondary to punctate inner choroidopathy
Study objectives	The aim of this study is to see whether intravitreal injection conbercept in “PRN” regime is safe and effective to improve vision and anatomical outcomes in patients with naïve choroidal neovascularization secondary to punctate inner choroidopathy.
Ethics approval(s)	Zhongshan Ophthalmic Center of Sun Yat-sen Universit Medical Ethics Board, 27/02/2015, ref: 2015MEKY020
Health condition(s) or problem(s) studied	Active subfoveal or juxatoveal CNV secondary to punctate inner choroidopathy
Intervention	Participants who require treatment for CNV receive a single intravitreal injection of 0.5mg conbercept at baseline. Reinjection is given if intraretinal edema or subretinal fluid is observed with optical coherence tomography (OCT) or if leakage within the lesion is observed with fluorescein angiography (FA). Participants are followed up with monthly visits for six months. They are assessed for their best corrected visual acuity (BCVA).Participants anatomical features are assessed with OCT at each monthly visit, FA and indocyanine green angiography (ICGA) at baseline and six months. The researchers collect this information by reviewing medical records in order to see how effective and safe this treatment is.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	conbercept
Primary outcome measure(s)	1. Visual outcomes (best-corrected visual acuity BCVA) are measured using an eye test at baseline, and month one, two, three, four, five and six 2. Anatomical outcomes (CRT, subretinal or intraretinal fluid build up) is measured manually based on patients’ OCT images using a scale of Heidelberg software at baseline and month one, two, three, four, five and six 3. Angiographic leakage is measured by fluorescein angiography (FA) images at month one, two, three, four, five and six 4. Number of treatments is measured using patient interviews at month one, two, three, four, five and six 5. Adverse events are measured using patient interviews at month one, two, three, four, five and six month
Key secondary outcome measure(s)	1. The change in the size of choroidal neovascularization (CNV) is measured using patients’ fluorescein angiography (FA) images at baseline and month six 2. The change in number or size of punctate inner choroidopathy (PIC) lesions is measured using patients’ indocyanine green angiography images at baseline and month six
Completion date	26/11/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	16
Key inclusion criteria	1. Active subfoveal or juxatoveal CNV secondary to PIC, where PIC was defined as multiple, small yellow-white lesions or atrophy in the posterior pole that had typical manifestations on optical coherence tomography (OCT) images 2. PIC lesions observed around the CNV. CNV was considered active if leakage within the lesion are observed with fluorescein angiography (FA) or intraretinal edema or subretinal fluid was observed with OCT 3. Adults aged 18 and older
Key exclusion criteria	1. CNV was secondary to other causes, such as AMD, PCV, fundus angioid streaks, or trauma 2. Presence of any other ophthalmic diseases 3. Prior treatment of CNV, including thermal laser photocoagulation, submacular surgery, intravitreal any anti-VEGF drugs, and photodynamic therapy (PDT) 4. Administration immunosuppressants or corticosteroids (local or systemic) in observation period 5. Presence of systemic diseases or pregnancy
Date of first enrolment	01/05/2015
Date of final enrolment	30/06/2016

Locations

Countries of recruitment

China

Study participating centre

Zhongshan Ophthalmic Center

Sun Yat-sen University
54 South Xianlie Road
Guangzhou
510060
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Pengyuting at pengyuting08@163.com

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/06/2017	31/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/01/2019: Publication reference added
06/06/2017: Internal review.