Ozurdex in Reducing PVR After Vitreotomy in PDR

Not Applicable

• Conditions: Diabetic Retinopathy

• Registration Number: NCT05415826
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Study First Posted: 2022-06-13
• Last Update Posted: 2022-06-13
• Study Start: 2022-06-15
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PVR	during 3 months after surgery	proliferative vitreoretinopathy after sugery
CRT	from preoperation to 3 months follow-up	central retina thickness

Secondary Outcome Measures

Name	Time	Method
Intraretinal hemorrhage	during 3 months after surgery	Intraretinal hemorrhage
BCVA	from preoperation to 3 months follow-up	best corrected visual acuity