- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03971162
Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization
March 29, 2023 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University
Choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV) is a common vision-threatening complication and often affects adults of working age.
Intravitreal injection of any anti-vascular endothelial growth factor (VEGF) drugs would significantly suppress the activity of the CNV and finally improve the visual acuity.
However, more than half of the patients would need one or more further injection for the recurrence or uncontrolled with 1+pro re nata (PRN) treatment within one year, and whether increasing the initial loading of intravitreal injection of anti-VEGF would be more efficacy for the controlling the PM-CNV remained unknown.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
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
- Name: lin lu
- Phone Number: +8620- 66683995
- Email: lulin888@126.com
Study Contact Backup
- Name: shida chen
- Phone Number: +8620- 66683995
- Email: chenshd3@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Zhongshan Ophthalmic Center
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are aged ≥18 years, male or female
Active choroidal neovascularization secondary to pathologic myopia
- high myopia (defined as spherical equivalent ≤-6.0 diopter, AL≥26mm)
- presence of posterior changes compatible with pathologic myopia
- presence of active leakage from CNV, and presence of intra-retinal or subretinal fluid or increase of central retinal thickness
Presence of at least 1 of the following lesion types:
- subfoveal
- juxtafoveal with involvement of the central macular area
- extrafoveal with involvement of the central macular area
- margin of the optic disk with involvement of the central macular area
- 24≤BCVA≤78, at a starting distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) like VA chart ( 20/32-20/320 Snellen equivalent)
- Visual loss only due to the presence of any eligible types of CNV related to pathologic myopia, based on clinical ocular findings, fluorescein angiography (FA), and optical coherence tomography (OCT) data.
- Patients who are willing to participant in this study and sign the informed consent
Exclusion Criteria:
- Pan-retinal or focal/grid laser photocoagulation with involvement of the macular area in the study eye at any time
- Intraocular treatment with corticosteroids or intraocular surgery within 3 months prior to randomization and treatment with anti-VEGF or verteporfin photodynamic therapy at any time in the study eye.
- Presence of CNV secondary to any cause other than pathologic myopia.
- Presence of active infectious disease or intraocular inflammation, active or suspected periocular infection or iris neovascularization in either eye at the time of enrollment.
- Pregnant or nursing women.
- Patients with other coexisting ocular diseases, such as an abnormal cornea or a corneal infection, iridocorneal endothelial syndrome, anterior segment dysgenesis, nanophthalmos, chronic or recurrent uveitis, ocular cancer, trauma, central retinal vein occlusion, central retinal artery occlusion, and retinal detachment).
- Patients with severe systemic disease and high risk when receiving intravitreous injection of anti-VEGF, such as diabetes mellitus, hypertension, end-stage cardiac disease, nephropathy, respiratory disease, cancer and HIV.
- Patients had stroke, transient ischemic attack, myocardial infarction, acute congestive heart failure within 6 months prior to randomization
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 |
Intervention / Treatment |
---|---|
Experimental: Group A
patients were given intravitreal injection of Conbercept 0.5mg every month repeated for 3 months.
Thereafter, intravitreal Conbercept 0.5mg injections should be administered in case CNV persisted or recurred (based on the assessment of defined criteria for retreatment) at a maximum frequency of once every 4 weeks through 12 months
|
intravitreal injection of Conbercept 0.5mg every month repeated for 3 months,
|
Experimental: Group B
patients were given intravitreal injection of Conbercept 0.5mg every month repeated for 6 months.Thereafter, intravitreal Conbercept 0.5mg injections should be administered in case CNV persisted or recurred (based on the assessment of defined criteria for retreatment) at a maximum frequency of once every 4 weeks through 12 months
|
intravitreal injection of Conbercept 0.5mg every month repeated for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BCVA change
Time Frame: 12 months
|
the mean change in BCVA from the baseline to month 12 in patients with PM-CNV receiving Conbercept 0.5mg 3+PRN or 6+PRN
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence rate of PM-CNV
Time Frame: 12 months
|
the number of recurrence of choroidal neovascularization secondary to pathologic myopia
|
12 months
|
BCVA at 3 years
Time Frame: 36 months
|
the change of best corrected visual acuity (BCVA) at 3 years
|
36 months
|
The change of CNV size
Time Frame: 12 months
|
the size of choroidal neovascularization as measured by OCT
|
12 months
|
The treatment exposure
Time Frame: 12 months
|
the number of total injection within 1 year and 3 years
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
June 13, 2019
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
January 1, 2023
Study Registration Dates
First Submitted
May 31, 2019
First Submitted That Met QC Criteria
May 31, 2019
First Posted (Actual)
June 3, 2019
Study Record Updates
Last Update Posted (Actual)
March 30, 2023
Last Update Submitted That Met QC Criteria
March 29, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019KYPJ072
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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