Ozurdex in Reducing PVR After Vitreotomy in PDR

Study Overview
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Brief Summary
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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
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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.

Official Title
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Slow-Release Dexamethasone in Reducing Proliferative Vitreoretinopathy After Vitreotomy in Proliferative Diabetic Retinopathy

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Procedure: slow-release dexamethasone implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PPV group<br>Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling. | Procedure: slow-release dexamethasone implant<br>* The eyes with proliferative diabetic retinopathy underwent PPV with silicone oil filling with or without slow-release dexamethasone implant at the end of surgery.<br>|
| Experimental: PPV+implant group<br>Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling and slow-release dexamethasone implant. | Procedure: slow-release dexamethasone implant<br>* The eyes with proliferative diabetic retinopathy underwent PPV with silicone oil filling with or without slow-release dexamethasone implant at the end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PVR | proliferative vitreoretinopathy after sugery | during 3 months after surgery | 
| CRT | central retina thickness | from preoperation to 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA | best corrected visual acuity | from preoperation to 3 months follow-up | 
| Intraretinal hemorrhage | Intraretinal hemorrhage | during 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDR; PVR; Ozurdex