Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

Myopic Choroidal Neovascularisation Clinical Trial

Official title:

Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971162
• Other study ID #: 2019KYPJ072
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia
• Myopic Choroidal Neovascularisation
• Neovascularization, Pathologic

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