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Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema, Diabetic Retinopathy, Cataract Diabetic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conbercept intravitreal injection
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Macular Edema

Eligibility Criteria

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

Inclusion Criteria:

  • Patients sign informed consent, and are willing and able to comply with all the follow-ups
  • Age ≥ 18 years , both genders
  • Diagnosis of type 1 or type 2 diabetes mellitus
  • Serum HbA1c ≤ 10%
  • Patients with a diagnosis of DR (ETDRS 35-53) and cataract

Exclusion Criteria:

  • CI-DME
  • Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy
  • History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases
  • Received anti- VEGF treatment (including intravitreal injection or systematic application) within three months prior to enrollment
  • History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to enrollment, or possibly need panretinal photocoagulation of the study eye during the study
  • Intraocular conventional surgery within the past three months
  • Traumatic cataract or congenital bilateral cataract in the study eye
  • Active ocular or periocular infection in either eye
  • Iris neovascularization in the study eye
  • Uncontrolled glaucoma, or history of glaucoma surgery
  • Aphakia in the study eye
  • History of vitrectomy in the study eye
  • The density of corneal endothelial cells is lower than 2000/mm2
  • Patients with uncontrolled hyperglycemia, or Hemoglobin A1C (HbA1c) ≥10.0%, or under hemodialysis, or started insulin usage within the last 4 months, or expected to start insulin use for hyperglycemia control in the next 4 months
  • Any surgical contraindications
  • Uncontrolled Blood Pressure
  • Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month
  • Renal Failure
  • Pregnant or breast-feeding women
  • Participation in another simultaneous medical investigator or trial
  • Other situations where the researcher judges that the patient is not suitable for inclusion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    combined cataract surgery and intravitreal Conbercept injection

    cataract surgery alone

    Arm Description

    Subjects will receive conbercept injections at a dose of 0.5 mg/eye at the conclusion of cataract surgery.

    Subjects will undergo cataract surgery by phacoemulsification and intraocular lens implantation.

    Outcomes

    Primary Outcome Measures

    change in central retinal thickness (CRT) with optical coherence tomography (OCT)
    to compare the mean change from baseline of CRT between treatment group and control group at month 1 and 3
    change in diabetic retinopathy severity score (DRSS)
    to compare the mean change from baseline of DRSS between treatment group and control group at month 1 and 3

    Secondary Outcome Measures

    change in best corrected visual acuity (BCVA)
    change in foveal avascular zone (FAZ) with optical coherence tomography angiography (OCTA)
    change in retinal vessel density (VD) with optical coherence tomography angiography (OCTA)
    change in the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8

    Full Information

    First Posted
    December 9, 2020
    Last Updated
    December 9, 2020
    Sponsor
    Eye & ENT Hospital of Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04668703
    Brief Title
    Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema
    Official Title
    Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema in Cataract Patients With Diabetic Retinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    November 1, 2021 (Anticipated)
    Study Completion Date
    January 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eye & ENT Hospital of Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Diabetic macular edema (DME) is an important cause of central vision impairment among people with diabetic retinopathy (DR), which can have a significant adverse effect on daily activities and quality of life. Diabetic patients with preexisting DME are at increased risk of worsening edema following cataract surgery. Previous studies also reported progression of DR after cataract surgery. Clinically significant DME is now classified into center-involved DME (CI-DME) and non center-involved DME (non-CI DME). Randomized clinical trials have established intravitreal antivascular endothelial growth factor (VEGF) therapy as first-line treatment for visual impairment from CI-DME and studies have addressed the influence of anti-VEGF therapy among patients with DME undergoing cataract surgery. However, for patients with non-CI DME before cataract surgery, whether anti-VEGF therapy is necessary at the end of surgery to prevent CI-DME is still clinically controversial. In order to evaluate the prophylactic effect of Conbercept (a recombinant fusion protein with high affinity to all VEGF isoforms and PIGF) intravitreal injection at the conclusion of cataract surgery for DME in patients with DR, the investigators will prospectively recruit 40 cataract patients with DR and non-CI DME and randomly assign these subjects into the study group (combined cataract surgery and intravitreal Conbercept injection, 20 cases) and the control group (cataract surgery alone, 20 cases). The primary outcomes include mean changes in central retinal thickness (CRT) and in diabetic retinopathy severity score (DRSS). The secondary outcomes include changes in best corrected visual acuity (BCVA), foveal avascular zone (FAZ), retinal vessel density (VD), the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Macular Edema, Diabetic Retinopathy, Cataract Diabetic

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    combined cataract surgery and intravitreal Conbercept injection
    Arm Type
    Experimental
    Arm Description
    Subjects will receive conbercept injections at a dose of 0.5 mg/eye at the conclusion of cataract surgery.
    Arm Title
    cataract surgery alone
    Arm Type
    No Intervention
    Arm Description
    Subjects will undergo cataract surgery by phacoemulsification and intraocular lens implantation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conbercept intravitreal injection
    Intervention Description
    intravitreal injection of 0.5 mg conbercept at the conclusion of cataract surgery
    Primary Outcome Measure Information:
    Title
    change in central retinal thickness (CRT) with optical coherence tomography (OCT)
    Description
    to compare the mean change from baseline of CRT between treatment group and control group at month 1 and 3
    Time Frame
    Baseline, 1 month and 3 month after operation
    Title
    change in diabetic retinopathy severity score (DRSS)
    Description
    to compare the mean change from baseline of DRSS between treatment group and control group at month 1 and 3
    Time Frame
    Baseline, 1 month and 3 month after operation
    Secondary Outcome Measure Information:
    Title
    change in best corrected visual acuity (BCVA)
    Time Frame
    Baseline, 1 month and 3 month after operation
    Title
    change in foveal avascular zone (FAZ) with optical coherence tomography angiography (OCTA)
    Time Frame
    Baseline, 1 month and 3 month after operation
    Title
    change in retinal vessel density (VD) with optical coherence tomography angiography (OCTA)
    Time Frame
    Baseline, 1 month and 3 month after operation
    Title
    change in the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8
    Time Frame
    Baseline, 1 week, 1 month and 3 month after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients sign informed consent, and are willing and able to comply with all the follow-ups Age ≥ 18 years , both genders Diagnosis of type 1 or type 2 diabetes mellitus Serum HbA1c ≤ 10% Patients with a diagnosis of DR (ETDRS 35-53) and cataract Exclusion Criteria: CI-DME Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases Received anti- VEGF treatment (including intravitreal injection or systematic application) within three months prior to enrollment History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to enrollment, or possibly need panretinal photocoagulation of the study eye during the study Intraocular conventional surgery within the past three months Traumatic cataract or congenital bilateral cataract in the study eye Active ocular or periocular infection in either eye Iris neovascularization in the study eye Uncontrolled glaucoma, or history of glaucoma surgery Aphakia in the study eye History of vitrectomy in the study eye The density of corneal endothelial cells is lower than 2000/mm2 Patients with uncontrolled hyperglycemia, or Hemoglobin A1C (HbA1c) ≥10.0%, or under hemodialysis, or started insulin usage within the last 4 months, or expected to start insulin use for hyperglycemia control in the next 4 months Any surgical contraindications Uncontrolled Blood Pressure Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month Renal Failure Pregnant or breast-feeding women Participation in another simultaneous medical investigator or trial Other situations where the researcher judges that the patient is not suitable for inclusion
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jin Yang, MD, ph.D.
    Phone
    +8613671632525
    Email
    jin_er76@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yumeng Shi, MD
    Phone
    +8619945616479
    Email
    mengmenger123@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jin Yang, MD, ph.D.
    Organizational Affiliation
    Eye & ENT Hospital of Fudan University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32402554
    Citation
    Glassman AR, Wells JA 3rd, Josic K, Maguire MG, Antoszyk AN, Baker C, Beaulieu WT, Elman MJ, Jampol LM, Sun JK. Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study). Ophthalmology. 2020 Sep;127(9):1201-1210. doi: 10.1016/j.ophtha.2020.03.021. Epub 2020 Mar 29.
    Results Reference
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    PubMed Identifier
    29902977
    Citation
    Zhang J, Liang Y, Xie J, Li D, Hu Q, Li X, Zheng W, He R. Conbercept for patients with age-related macular degeneration: a systematic review. BMC Ophthalmol. 2018 Jun 15;18(1):142. doi: 10.1186/s12886-018-0807-1.
    Results Reference
    background
    PubMed Identifier
    28151747
    Citation
    Relhan N, Flynn HW Jr. The Early Treatment Diabetic Retinopathy Study historical review and relevance to today's management of diabetic macular edema. Curr Opin Ophthalmol. 2017 May;28(3):205-212. doi: 10.1097/ICU.0000000000000362.
    Results Reference
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    PubMed Identifier
    29144826
    Citation
    Peterson SR, Silva PA, Murtha TJ, Sun JK. Cataract Surgery in Patients with Diabetes: Management Strategies. Semin Ophthalmol. 2018;33(1):75-82. doi: 10.1080/08820538.2017.1353817. Epub 2017 Nov 16.
    Results Reference
    background
    PubMed Identifier
    31137510
    Citation
    Grzybowski A, Kanclerz P, Huerva V, Ascaso FJ, Tuuminen R. Diabetes and Phacoemulsification Cataract Surgery: Difficulties, Risks and Potential Complications. J Clin Med. 2019 May 20;8(5):716. doi: 10.3390/jcm8050716.
    Results Reference
    background
    PubMed Identifier
    27651226
    Citation
    Heier JS, Korobelnik JF, Brown DM, Schmidt-Erfurth U, Do DV, Midena E, Boyer DS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Vitti R, Berliner AJ, Zeitz O, Metzig C, Holz FG. Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology. 2016 Nov;123(11):2376-2385. doi: 10.1016/j.ophtha.2016.07.032. Epub 2016 Sep 17.
    Results Reference
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    PubMed Identifier
    28284785
    Citation
    Ip MS, Zhang J, Ehrlich JS. The Clinical Importance of Changes in Diabetic Retinopathy Severity Score. Ophthalmology. 2017 May;124(5):596-603. doi: 10.1016/j.ophtha.2017.01.003. Epub 2017 Mar 8.
    Results Reference
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    PubMed Identifier
    28764888
    Citation
    Dhoot DS, Baker K, Saroj N, Vitti R, Berliner AJ, Metzig C, Thompson D, Singh RP. Baseline Factors Affecting Changes in Diabetic Retinopathy Severity Scale Score After Intravitreal Aflibercept or Laser for Diabetic Macular Edema: Post Hoc Analyses from VISTA and VIVID. Ophthalmology. 2018 Jan;125(1):51-56. doi: 10.1016/j.ophtha.2017.06.029. Epub 2017 Jul 29.
    Results Reference
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    Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema

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