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Ozurdex in Reducing PVR After Vitreotomy in PDR

Primary Purpose

Diabetic Retinopathy

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 Diabetic Retinopathy focused on measuring PDR; PVR; Ozurdex

Eligibility Criteria

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

Inclusion Criteria:

  • macula off treatment naive TRD second to PDR causing visual loss;
  • treated by standardize PPV, endolaser and silicone oil tamponade with or without DEX implant at the end of the surgery within 12 months from diagnosis of TRD;
  • Hba1c is less than 10% with type 1 or 2 diabetes mellitus

Exclusion Criteria:

  • other concomitant ocular diseases that cause RD ( for example rhegmatogenous retinal detachment, exudative retinal detachment, other causes for TRD);
  • any previous injection of DEX implant;
  • abnormalities of the vitreoretinal interface, such as epiretinal membrane, vitreomacular traction without RD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    PPV group

    PPV+implant group

    Arm Description

    Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling.

    Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling and slow-release dexamethasone implant.

    Outcomes

    Primary Outcome Measures

    PVR
    proliferative vitreoretinopathy after sugery
    CRT
    central retina thickness

    Secondary Outcome Measures

    BCVA
    best corrected visual acuity
    Intraretinal hemorrhage
    Intraretinal hemorrhage

    Full Information

    First Posted
    June 8, 2022
    Last Updated
    June 8, 2022
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05415826
    Brief Title
    Ozurdex in Reducing PVR After Vitreotomy in PDR
    Official Title
    Slow-Release Dexamethasone in Reducing Proliferative Vitreoretinopathy After Vitreotomy in Proliferative Diabetic Retinopathy
    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
    Diabetic retinopathy is a significant source of visual morbidity in the adult population. Complications of diabetic retinopathy include ischemic maculopathy, macular edema, and sequelae of fibrovascular proliferation, such as vitreous hemorrhage (VH), tractional retinal detachment (TRD), and neovascular glaucoma.Pars plana vitrectomy (PPV) is traditionally performed for nonclearing VH, significant fibrovascular proliferation, refractive macular edema, and/or TRD, particularly if macula-involving. However, the pathogenesis is complex and multifactorial: Pro-infammatory cytokines and chemokines signifcantly contribute to the disease development and promote ischemic changes in the retina. Therefore, there is a potential role for intravitreal steroids in disease modifcation.
    Detailed Description
    Diabetic retinopathy is a significant source of visual morbidity in the adult population. Complications of diabetic retinopathy include ischemic maculopathy, macular edema, and sequelae of fibrovascular proliferation, such as vitreous hemorrhage (VH), tractional retinal detachment (TRD), and neovascular glaucoma.Pars plana vitrectomy (PPV) is traditionally performed for nonclearing VH, significant fibrovascular proliferation, refractive macular edema, and/or TRD, particularly if macula-involving. However, the pathogenesis is complex and multifactorial: Pro-infammatory cytokines and chemokines signifcantly contribute to the disease development and promote ischemic changes in the retina. Therefore, there is a potential role for intravitreal steroids in disease modifcation. Corticosteroids reduce not only leukostasis and infammatory cytokine production, but also VEGF expression. Experimentally, corticosteroids potentially can influence both the inflammatory and the proliferative components of the PVR process via a variety of modes of administration without evidence of demonstrable retinal toxicity. So, this study is carried out for the purpose of investigating the efficacy of slow-release dexamethasone implant in proliferative vitreoretinopathy of postoperative proliferative diabetic retinopathy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Retinopathy
    Keywords
    PDR; PVR; Ozurdex

    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
    Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling.
    Arm Title
    PPV+implant group
    Arm Type
    Experimental
    Arm Description
    Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling and slow-release dexamethasone implant.
    Intervention Type
    Procedure
    Intervention Name(s)
    slow-release dexamethasone implant
    Intervention Description
    The eyes with proliferative diabetic retinopathy underwent PPV with silicone oil filling with or without slow-release dexamethasone implant at the end of surgery.
    Primary Outcome Measure Information:
    Title
    PVR
    Description
    proliferative vitreoretinopathy after sugery
    Time Frame
    during 3 months after surgery
    Title
    CRT
    Description
    central retina thickness
    Time Frame
    from preoperation to 3 months follow-up
    Secondary Outcome Measure Information:
    Title
    BCVA
    Description
    best corrected visual acuity
    Time Frame
    from preoperation to 3 months follow-up
    Title
    Intraretinal hemorrhage
    Description
    Intraretinal hemorrhage
    Time Frame
    during 3 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: macula off treatment naive TRD second to PDR causing visual loss; treated by standardize PPV, endolaser and silicone oil tamponade with or without DEX implant at the end of the surgery within 12 months from diagnosis of TRD; Hba1c is less than 10% with type 1 or 2 diabetes mellitus Exclusion Criteria: other concomitant ocular diseases that cause RD ( for example rhegmatogenous retinal detachment, exudative retinal detachment, other causes for TRD); any previous injection of DEX implant; abnormalities of the vitreoretinal interface, such as epiretinal membrane, vitreomacular traction without RD
    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
    9627648
    Citation
    Moss SE, Klein R, Klein BE. The 14-year incidence of visual loss in a diabetic population. Ophthalmology. 1998 Jun;105(6):998-1003. doi: 10.1016/S0161-6420(98)96025-0.
    Results Reference
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    PubMed Identifier
    10030553
    Citation
    Fong DS, Ferris FL 3rd, Davis MD, Chew EY. Causes of severe visual loss in the early treatment diabetic retinopathy study: ETDRS report no. 24. Early Treatment Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 1999 Feb;127(2):137-41. doi: 10.1016/s0002-9394(98)00309-2.
    Results Reference
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    PubMed Identifier
    2196036
    Citation
    Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial: Diabetic Retinopathy Vitrectomy Study Report 5. Arch Ophthalmol. 1990 Jul;108(7):958-64. doi: 10.1001/archopht.1990.01070090060040. Erratum In: Arch Ophthalmol 1990 Oct;108(10):1452.
    Results Reference
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    PubMed Identifier
    28510630
    Citation
    Vujosevic S, Simo R. Local and Systemic Inflammatory Biomarkers of Diabetic Retinopathy: An Integrative Approach. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO68-BIO75. doi: 10.1167/iovs.17-21769.
    Results Reference
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    PubMed Identifier
    15258777
    Citation
    Funatsu H, Yamashita H, Noma H, Mimura T, Nakamura S, Sakata K, Hori S. Aqueous humor levels of cytokines are related to vitreous levels and progression of diabetic retinopathy in diabetic patients. Graefes Arch Clin Exp Ophthalmol. 2005 Jan;243(1):3-8. doi: 10.1007/s00417-004-0950-7. Epub 2004 Jul 17.
    Results Reference
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    PubMed Identifier
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    Citation
    Schwartzman ML, Iserovich P, Gotlinger K, Bellner L, Dunn MW, Sartore M, Grazia Pertile M, Leonardi A, Sathe S, Beaton A, Trieu L, Sack R. Profile of lipid and protein autacoids in diabetic vitreous correlates with the progression of diabetic retinopathy. Diabetes. 2010 Jul;59(7):1780-8. doi: 10.2337/db10-0110. Epub 2010 Apr 27.
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    PubMed Identifier
    19509100
    Citation
    Goldberg RB. Cytokine and cytokine-like inflammation markers, endothelial dysfunction, and imbalanced coagulation in development of diabetes and its complications. J Clin Endocrinol Metab. 2009 Sep;94(9):3171-82. doi: 10.1210/jc.2008-2534. Epub 2009 Jun 9.
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    PubMed Identifier
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    Citation
    dell'Omo R, Semeraro F, Bamonte G, Cifariello F, Romano MR, Costagliola C. Vitreous mediators in retinal hypoxic diseases. Mediators Inflamm. 2013;2013:935301. doi: 10.1155/2013/935301. Epub 2013 Jan 10.
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    Citation
    Albini TA, Abd-El-Barr MM, Carvounis PE, Iyer MN, Lakhanpal RR, Pennesi ME, Chevez-Barrios P, Wu SM, Holz ER. Long-term retinal toxicity of intravitreal commercially available preserved triamcinolone acetonide (Kenalog) in rabbit eyes. Invest Ophthalmol Vis Sci. 2007 Jan;48(1):390-5. doi: 10.1167/iovs.06-0145.
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