Condition category
Eye Diseases
Date applied
12/08/2016
Date assigned
24/08/2016
Last edited
24/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Age-related macular degeneration (AMD) is one of the leading causes of blindness in elderly people in Western countries. In recent years, the incidence of AMD in China has also increased. Wet AMD is caused by abnormal blood vessels growing in the eye. Vascular endothelial growth factor (VEGF) is one of the chemicals responsible for the growth of these blood vessels. Anti-VEGF medicines block this chemical, stopping it from producing blood vessels and preventing wet AMD from getting worse. Conbercept is an anti-VEGF drug that blocks all the different forms of VEGF-A, VEGF-B, VEGF-C and placenta growth factor (PlGF), whereas ranibizumab only blocks VEGF-A. The aim of this study is to compare conbercept and ranibizumab for the treatment of wet AMD.

Who can participate?
Patients aged 51–85 with active wet AMD in one eye

What does the study involve?
Participants are randomly allocated to be treated with either conbercept or ranibizumab. The interval between treatments is individually tailored based on the disease activity of each patient. Patients are treated no more frequently than every 4 weeks and no less frequently than every 12 weeks. If there are no signs of active disease, the period to the next treatment is extended by 2 weeks, up to a maximum interval of 12 weeks. Visual acuity (clarity of vision) is measured in both groups after one year.

What are the possible benefits and risks of participating?
No benefits are expected for the participants, but this study will improve the future treatment of AMD patients. Patients receiving an injection of any of the drugs may experience less severe side effects related to the pre-injection preparation procedure. These side effects may include eye pain, subconjunctival hemorrhage (bloodshot eye), vitreous floaters, irregularity or swelling of the cornea, inflammation of the eye, and visual disturbances. There is no additional risk involved in this study.

Where is the study run from?
1. The First Hospital of Qiqihar City (China)
2. The Second Affiliated Hospital of Harbin Medical University (China)
3. Peking Union Medical College Hospital (China)
4. The Third Affiliated Hospital of Qiqihar Medical University (China)

When is the study starting and how long is it expected to run for?
May 2014 to May 2016

Who is funding the study?
1. The First Hospital of Qiqihar City (China)
2. National Natural Science Foundation of China (China)
3. Research to Prevent Blindness (USA)

Who is the main contact?
Dr Jinglin Cui

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jinglin Cui

ORCID ID

Contact details

Center of Integrative Research
The First Hospital of Qiqihar City
30 Gongyuan Road
Longsha District
Qiqihaer
161005
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2006… 003

Study information

Scientific title

Comparison of effectiveness and safety between conbercept and ranibizumab for treatment of neovascular age-related macular degeneration

Acronym

Study hypothesis

Conbercept is better than ranibizumab for the treatment of neovascular age-related macular degeneration.

Ethics approval

The First Hospital of Qiqihar institutional review board, 02/05/2014, ref: FHQQ2006-003

Study design

Multicenter retrospective randomly selected study with a noninferiority limit of five letters

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Age-related macular degeneration

Intervention

Between May 2014 and May 2015, 180 patients were randomly collected in a 1:1 ratio for treatments using conbercept or ranibizumab (n=90 in each cohort) from these four centers. These patients were randomly picked up from the patients of conbercept or ranibizumab groups without any information except the names of drugs. The patients selectively received intravitreal injections of conbercept 0.5 mg (0.05 ml) or ranibizumab 0.5 mg (0.05 ml) following a TREX protocol. Intravitreal injections were completed by experienced ophthalmologists and were masked. According to TREX management, beginning at the third monthly treatment, the interval between treatments was individually tailored based upon the exudative disease activity of each patient. Patients were treated no more frequently than every 4 weeks and no less frequently than every 12 weeks. An Inactive CNV lesion was achieved upon resolution of intraretinal and subretinal fluid on the optical coherence tomography (OCT) examination and upon resolution of subretinal and intraretinal hemorrhage related to exudative AMD, as determined by fundus examination. If there were no signs of active neovascular disease, the period to the next treatment was extended by 2 weeks, up to a maximum interval of 12 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Conbercept, ranibizumab

Primary outcome measures

Best-corrected visual acuity (BCVA), as determined using the ETDRS chart at one year

Secondary outcome measures

1. The number of injections counted at the end of one year follow-up
2. Retinal thickness measured at every visit by OCT
3. Leakage of CNV measured at every visit by fundus fluorescein angiography (FFA)
4. Ocular complications measured at every visit by ophthalmologist examination

Overall trial start date

02/05/2014

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 51–85 years
2. Previously untreated active neovascular AMD in one eye
3. Absence of other ocular diseases determined by examination using a tonometer, slit lamp biomicroscope and ophthalmoscope
4. Lack of polypoidal choroidal vasculopathy (PCV) as determined by indocyanine green angiography (ICGA)
5. Total area of the subretinal hemorrhage and fibrosis comprised less than 50% of the total lesion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180 patients

Participant exclusion criteria

1. Other serious illness
2. Systematic diseases
3. Polypoidal choroidal vasculopathy (PCV)
4. Subretinal hemorrhage and fibrosis comprised more than 50% of the total lesion

Recruitment start date

02/05/2014

Recruitment end date

01/05/2015

Locations

Countries of recruitment

China

Trial participating centre

The First Hospital of Qiqihar City
161005
China

Trial participating centre

The Second Affiliated Hospital of Harbin Medical University
150086
China

Trial participating centre

Peking Union Medical College Hospital
100730
China

Trial participating centre

The Third Affiliated Hospital of Qiqihar Medical University
161000
China

Sponsor information

Organisation

The First Hospital of Qiqihar City

Sponsor details

Center of Integrative Research
The First Hospital of Qiqihar City
Qiqihar
161005
China

Sponsor type

Hospital/treatment centre

Website

http://www.qqhrdyyy.com.cn/

Funders

Funder type

Hospital/treatment centre

Funder name

The First Hospital of Qiqihar City

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Natural Science Foundation of China

Alternative name(s)

National Science Foundation of China, Natural Science Foundation of China, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

China

Funder name

Research to Prevent Blindness

Alternative name(s)

RPB

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

01/11/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes