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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03971162
Other study ID # 2019KYPJ072
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 13, 2019
Est. completion date January 1, 2023

Study information

Verified date February 2023
Source Zhongshan Ophthalmic Center, Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients who are aged =18 years, male or female 2. Active choroidal neovascularization secondary to pathologic myopia 1. high myopia (defined as spherical equivalent =-6.0 diopter, AL=26mm) 2. presence of posterior changes compatible with pathologic myopia 3. presence of active leakage from CNV, and presence of intra-retinal or subretinal fluid or increase of central retinal thickness 3. Presence of at least 1 of the following lesion types: 1. subfoveal 2. juxtafoveal with involvement of the central macular area 3. extrafoveal with involvement of the central macular area 4. margin of the optic disk with involvement of the central macular area 4. 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) 5. 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. 6. 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
3+PRN
intravitreal injection of Conbercept 0.5mg every month repeated for 3 months,
6+PRN
intravitreal injection of Conbercept 0.5mg every month repeated for 6 months

Locations

Country Name City State
China Zhongshan Ophthalmic Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary BCVA change 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 Recurrence rate of PM-CNV the number of recurrence of choroidal neovascularization secondary to pathologic myopia 12 months
Secondary BCVA at 3 years the change of best corrected visual acuity (BCVA) at 3 years 36 months
Secondary The change of CNV size the size of choroidal neovascularization as measured by OCT 12 months
Secondary The treatment exposure the number of total injection within 1 year and 3 years 12 months
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