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Ozurdex in Reducing PVR After Vitreotomy in PDR

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ClinicalTrials.gov Identifier: NCT05415826
Recruitment Status : Not yet recruiting
First Posted : June 13, 2022
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Procedure: slow-release dexamethasone implant Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Slow-Release Dexamethasone in Reducing Proliferative Vitreoretinopathy After Vitreotomy in Proliferative Diabetic Retinopathy
Estimated Study Start Date : June 15, 2022
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : September 15, 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PPV group
Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling.
 Procedure: slow-release dexamethasone implant
The eyes with proliferative diabetic retinopathy underwent PPV with silicone oil filling with or without slow-release dexamethasone implant at the end of surgery.
Experimental: PPV+implant group
Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling and slow-release dexamethasone implant.
 Procedure: slow-release dexamethasone implant
The eyes with proliferative diabetic retinopathy underwent PPV with silicone oil filling with or without slow-release dexamethasone implant at the end of surgery.


Outcome Measures
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Primary Outcome Measures :
  1. PVR [ Time Frame: during 3 months after surgery ]
    proliferative vitreoretinopathy after sugery

  2. CRT [ Time Frame: from preoperation to 3 months follow-up ]
    central retina thickness


Secondary Outcome Measures :
  1. BCVA [ Time Frame: from preoperation to 3 months follow-up ]
    best corrected visual acuity

  2. Intraretinal hemorrhage [ Time Frame: during 3 months after surgery ]
    Intraretinal hemorrhage


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:

  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05415826


Contacts
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Contact: Jinfeng Qu, MD +861088326666 Jinfeng_QuPKU@163.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Chair: Jinfeng Qu, MD Peking University People's Hospital
More Information
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Publications:

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT05415826    
Other Study ID Numbers: PKUPHoph
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
PDR; PVR; Ozurdex
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Dexamethasone
Anti-Inflammatory Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents