Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    150
  • sponsor
    Zhongshan Ophthalmic Center, Sun Yat-sen University
Updated on 2 May 2021

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.

Details
Condition Myopic Choroidal Neovascularisation
Treatment 3+PRN, 6+PRN
Clinical Study IdentifierNCT03971162
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
Last Modified on2 May 2021

Eligibility

Yes No Not Sure

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, AL26mm)
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
24BCVA78, 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
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