Ozurdex in Reducing PVR After Vitreotomy in PDR
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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.
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| 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
Primary Outcome Measures
- PVR [during 3 months after surgery]
proliferative vitreoretinopathy after sugery
- CRT [from preoperation to 3 months follow-up]
central retina thickness
Secondary Outcome Measures
- BCVA [from preoperation to 3 months follow-up]
best corrected visual acuity
- Intraretinal hemorrhage [during 3 months after surgery]
Intraretinal hemorrhage
Eligibility Criteria
Criteria
Inclusion Criteria:
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macula off treatment naive TRD second to PDR causing visual loss;
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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;
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Hba1c is less than 10% with type 1 or 2 diabetes mellitus
Exclusion Criteria:
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other concomitant ocular diseases that cause RD ( for example rhegmatogenous retinal detachment, exudative retinal detachment, other causes for TRD);
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any previous injection of DEX implant;
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abnormalities of the vitreoretinal interface, such as epiretinal membrane, vitreomacular traction without RD
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University People's Hospital
Investigators
- Study Chair: Jinfeng Qu, MD, Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
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- 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. Erratum in: Arch Ophthalmol 1990 Oct;108(10):1452.
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- 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. Review.
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- 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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- PKUPHoph