Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

Not Applicable

Completed

• Conditions: Myopic Choroidal Neovascularisation
• Interventions: Drug: 3+PRN; Drug: 6+PRN

• Registration Number: NCT03971162
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Study Start: 2019-06-13
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	3+PRN	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
Group B	6+PRN	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

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China