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Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

Primary Purpose

Myopic Choroidal Neovascularisation

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

3+PRN

6+PRN

About this trial

This is an interventional treatment trial for Myopic Choroidal Neovascularisation focused on measuring Choroidal Neovascularisation, Pathologic myopia, anti-VEGF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who are aged ≥18 years, male or female
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
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
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

Sites / Locations

Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Recurrence rate of PM-CNV

the number of recurrence of choroidal neovascularization secondary to pathologic myopia

BCVA at 3 years

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

The change of CNV size

the size of choroidal neovascularization as measured by OCT

The treatment exposure

the number of total injection within 1 year and 3 years

Full Information

NCT ID

NCT03971162

First Posted

May 31, 2019

Last Updated

March 29, 2023

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03971162

Brief Title

Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

Official Title

Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

June 13, 2019 (Actual)

Primary Completion Date

December 1, 2022 (Actual)

Study Completion Date

January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopic Choroidal Neovascularisation

Keywords

Choroidal Neovascularisation, Pathologic myopia, anti-VEGF

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Arm Title

Group B

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

3+PRN

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

6+PRN

Intervention Description

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

Primary Outcome Measure Information:

Title

BCVA change

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Recurrence rate of PM-CNV

Description

the number of recurrence of choroidal neovascularization secondary to pathologic myopia

Time Frame

12 months

Title

BCVA at 3 years

Description

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

Time Frame

36 months

Title

The change of CNV size

Description

the size of choroidal neovascularization as measured by OCT

Time Frame

12 months

Title

The treatment exposure

Description

the number of total injection within 1 year and 3 years

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

lin lu

Organizational Affiliation

Zhongshan Ophthalmic Center, Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Ophthalmic Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

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Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

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