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出境医 / 临床实验 / Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization

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.

Condition or disease Intervention/treatment Phase
Myopic Choroidal Neovascularisation Drug: 3+PRN Drug: 6+PRN Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Group A
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
intravitreal injection of Conbercept 0.5mg every month repeated for 3 months,
Experimental: Group B
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
intravitreal injection of Conbercept 0.5mg every month repeated for 6 months
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: lin lu +8620- 66683995 lulin888@126.com
Contact: shida chen +8620- 66683995 chenshd3@mail.sysu.edu.cn

Locations
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China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: shida chen    +862066683995    chenshd3@mail.sysu.edu.cn   
Contact: lin lu    +862066683995    lulin888@126.com   
Principal Investigator: lin lu         
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Investigators
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Principal Investigator: lin lu Zhongshan Ophthalmic Center, Sun Yat-sen University
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date April 21, 2021
Actual Study Start Date  ICMJE June 13, 2019
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2019)
  • Recurrence rate of PM-CNV [ Time Frame: 12 months ]
    the number of recurrence of choroidal neovascularization secondary to pathologic myopia
  • BCVA at 3 years [ Time Frame: 36 months ]
    the change of best corrected visual acuity (BCVA) at 3 years
  • The change of CNV size [ Time Frame: 12 months ]
    the size of choroidal neovascularization as measured by OCT
  • The treatment exposure [ Time Frame: 12 months ]
    the number of total injection within 1 year and 3 years
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Recurrence rate of PM-CNV [ Time Frame: 12 months ]
    the number of recurrence of choroidal neovascularization secondary to pathologic myopia
  • BCVA at 3 years [ Time Frame: 36 months ]
    the change of best corrected visual acuity (BCVA) at 3 years
  • The anatomical change of CNV [ Time Frame: 12 months ]
    the size of choroidal neovascularization, the anatomical change of retina and choroid
  • The treatment exposure [ Time Frame: 12 months ]
    the number of total injection within 1 year and 3 years
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization
Official Title  ICMJE Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myopic Choroidal Neovascularisation
Intervention  ICMJE
  • Drug: 3+PRN
    intravitreal injection of Conbercept 0.5mg every month repeated for 3 months,
  • Drug: 6+PRN
    intravitreal injection of Conbercept 0.5mg every month repeated for 6 months
Study Arms  ICMJE
  • Experimental: Group A
    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
    Intervention: Drug: 3+PRN
  • Experimental: Group B
    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
    Intervention: Drug: 6+PRN
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: lin lu +8620- 66683995 lulin888@126.com
Contact: shida chen +8620- 66683995 chenshd3@mail.sysu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971162
Other Study ID Numbers  ICMJE 2019KYPJ072
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Sponsor  ICMJE Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: lin lu Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Zhongshan Ophthalmic Center, Sun Yat-sen University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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