Skip to main content
OpenTrials
Completed

NCT Number: NCT03971162

Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3+PRN

Drug

intravitreal injection of Conbercept 0.5mg every month repeated for 3 months,

6+PRN

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Recurrence rate of PM-CNV

    Time frame: 12 months

    the number of recurrence of choroidal neovascularization secondary to pathologic myopia

  2. BCVA at 3 years

    Time frame: 36 months

    the change of best corrected visual acuity (BCVA) at 3 years

  3. The change of CNV size

    Time frame: 12 months

    the size of choroidal neovascularization as measured by OCT

  4. The treatment exposure

    Time frame: 12 months

    the number of total injection within 1 year and 3 years

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jun 3, 2019
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.