search
Back to results

Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane

Primary Purpose

Epiretinal Membrane

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
slow-release dexamethasone implant
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiretinal Membrane focused on measuring Epiretinal Membrane; Ozurdex; PPV

Eligibility Criteria

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

Inclusion Criteria:

  • patients with a visually significant (BCVA<20/50) idiopathic epiretinal membrane.
  • ocular axial length less than 27.00 mm (optical biometry) associated with cataracts.

Exclusion Criteria:

  • concomitant or previous macular diseases (diabetic macular edema, retinal vein occlusion and agerelated macular degeneration).
  • secondary epiretinal membrane, other visually significant macular pathology and prior intravitreal triamcinolone acetonide injection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    PPV group

    PPV+implant Group

    Arm Description

    Epiretinal membrane eyes underwent PPV

    Epiretinal membrane eyes underwent PPV combined with Ozurdex implant

    Outcomes

    Primary Outcome Measures

    CMT
    central macular thickness
    IOP
    intraocular pressure
    BCVA
    best-corrected visual acuity

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2022
    Last Updated
    June 9, 2022
    Sponsor
    Peking University People's Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05416827
    Brief Title
    Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane
    Official Title
    Evaluation of Intraoperative Slow-release Dexamethasone Implant Used During Vitrectomy for Epiretinal Membrane
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2022 (Anticipated)
    Primary Completion Date
    September 15, 2022 (Anticipated)
    Study Completion Date
    September 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University People's Hospital

    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
    Epiretinal membrane (ERM) is a commonly encountered vitreoretinal interface anomaly with a prevalence of approximately 10% in the adult population. It is often treated with pars plana vitrectomy (PPV) and membrane peeling when symptomatic. PPV is generally successful at improving visual acuity (VA) and/or metamorphopsia. At times, however, visual recovery can be hindered by macular edema in the post-vitrectomy period. Ozurdex can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.
    Detailed Description
    Small gauge pars plana vitrectomy (PPV) with membrane peeling is used to successfully treat macular epiretinal membranes (ERMs) with a postoperative improvement of visual acuity in the majority of cases. Traditionally, the treatment of ERMs has been performed purely by peeling the membrane mechanically and then waiting for the intraretinal edema to resolve spontaneously. In the last few years, some publications raised the possibility that triamcinolone acetonide (TA),given as an intravitreal injection at the end of surgery, can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. Dexamethasone is a potent synthetic member of the glucocorticoid class of steroid drugs that has anti-inflammatory and immunosuppressant activity 30 times that of cortisol and 6 times that of triamcinolone. As the postoperative cystoid macular edema usually peaks 4 to 6 weeks after surgery the difference in the half life can be significant and explained the results in past publications. While the use of intravitreal TA as an adjuvant to PPV with membrane peel showed conflicting results. Only few publications demonstrated the effectiveness of Ozurdex in the treatment of macular edema in a vitrectomized eye, after ERM removal.So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epiretinal Membrane
    Keywords
    Epiretinal Membrane; Ozurdex; PPV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PPV group
    Arm Type
    Active Comparator
    Arm Description
    Epiretinal membrane eyes underwent PPV
    Arm Title
    PPV+implant Group
    Arm Type
    Experimental
    Arm Description
    Epiretinal membrane eyes underwent PPV combined with Ozurdex implant
    Intervention Type
    Procedure
    Intervention Name(s)
    slow-release dexamethasone implant
    Intervention Description
    Epiretinal membrane eyes underwent PPV combined with Ozurdex implant
    Primary Outcome Measure Information:
    Title
    CMT
    Description
    central macular thickness
    Time Frame
    from preoperation to 3 months follow-up
    Title
    IOP
    Description
    intraocular pressure
    Time Frame
    from preoperation to 3 months follow-up
    Title
    BCVA
    Description
    best-corrected visual acuity
    Time Frame
    from preoperation to 3 months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with a visually significant (BCVA<20/50) idiopathic epiretinal membrane. ocular axial length less than 27.00 mm (optical biometry) associated with cataracts. Exclusion Criteria: concomitant or previous macular diseases (diabetic macular edema, retinal vein occlusion and agerelated macular degeneration). secondary epiretinal membrane, other visually significant macular pathology and prior intravitreal triamcinolone acetonide injection.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jinfeng Qu, MD
    Phone
    +861088326666
    Email
    Jinfeng_QuPKU@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jinfeng Qu, MD
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25923959
    Citation
    Reilly G, Melamud A, Lipscomb P, Toussaint B. SURGICAL OUTCOMES IN PATIENTS WITH MACULAR PUCKER AND GOOD PREOPERATIVE VISUAL ACUITY AFTER VITRECTOMY WITH MEMBRANE PEELING. Retina. 2015 Sep;35(9):1817-21. doi: 10.1097/IAE.0000000000000558.
    Results Reference
    background
    PubMed Identifier
    33423352
    Citation
    Mao J, Xu Z, Lao J, Chen Y, Xu X, Wu S, Zheng Z, Liu B, Shen L. Assessment of macular microvasculature features before and after vitrectomy in the idiopathic macular epiretinal membrane using a grading system: An optical coherence tomography angiography study. Acta Ophthalmol. 2021 Nov;99(7):e1168-e1175. doi: 10.1111/aos.14753. Epub 2021 Jan 10.
    Results Reference
    background
    PubMed Identifier
    25102192
    Citation
    Yang HS, Kim JT, Joe SG, Lee JY, Yoon YH. Postoperative restoration of foveal inner retinal configuration in patients with epiretinal membrane and abnormally thick inner retina. Retina. 2015 Jan;35(1):111-9. doi: 10.1097/IAE.0000000000000276.
    Results Reference
    background
    PubMed Identifier
    12689886
    Citation
    Beer PM, Bakri SJ, Singh RJ, Liu W, Peters GB 3rd, Miller M. Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection. Ophthalmology. 2003 Apr;110(4):681-6. doi: 10.1016/S0161-6420(02)01969-3.
    Results Reference
    background
    PubMed Identifier
    16077349
    Citation
    Chin HS, Park TS, Moon YS, Oh JH. Difference in clearance of intravitreal triamcinolone acetonide between vitrectomized and nonvitrectomized eyes. Retina. 2005 Jul-Aug;25(5):556-60. doi: 10.1097/00006982-200507000-00002.
    Results Reference
    background
    PubMed Identifier
    25259834
    Citation
    Medeiros MD, Alkabes M, Navarro R, Garcia-Arumi J, Mateo C, Corcostegui B. Dexamethasone intravitreal implant in vitrectomized versus nonvitrectomized eyes for treatment of patients with persistent diabetic macular edema. J Ocul Pharmacol Ther. 2014 Nov;30(9):709-16. doi: 10.1089/jop.2014.0010. Epub 2014 Sep 26.
    Results Reference
    background
    PubMed Identifier
    21487341
    Citation
    Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c.
    Results Reference
    background

    Learn more about this trial

    Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane

    We'll reach out to this number within 24 hrs