Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

NCT03971162 | Completed DMC

• 1 other identifier: 2019KYPJ072
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopic Choroidal Neovascularisation

Keywords

Choroidal Neovascularisation; Pathologic myopia; anti-VEGF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Recurrence rate of PM-CNV

  12 months

• BCVA at 3 years

  36 months

• The change of CNV size

  12 months

• The treatment exposure

  12 months

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

3+PRN DRUG

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

Group A

6+PRN DRUG

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

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• lin lu

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 3, 2019
• Study Start: June 13, 2019
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-02

Locations

CN (1)