Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03971162

Collaborator

(none)

150

Enrollment

Location

Arms

53.6

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myopic Choroidal Neovascularisation	Drug: 3+PRN Drug: 6+PRN	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

Actual Study Start Date :

Jun 13, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Drug: 3+PRN

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

Drug: 6+PRN

intravitreal injection of Conbercept 0.5mg every month repeated for 6 months

Outcome Measures

Primary Outcome Measures

BCVA change [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

Secondary Outcome Measures

Recurrence rate of PM-CNV [12 months]
the number of recurrence of choroidal neovascularization secondary to pathologic myopia
BCVA at 3 years [36 months]
the change of best corrected visual acuity (BCVA) at 3 years
The change of CNV size [12 months]
the size of choroidal neovascularization as measured by OCT
The treatment exposure [12 months]
the number of total injection within 1 year and 3 years

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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