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
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring PDR; PVR; Ozurdex
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
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
NCT ID
NCT05415826
First Posted
June 8, 2022
Last Updated
June 8, 2022
Sponsor
Peking University People's Hospital
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
background
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
background
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
background
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
background
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
background
PubMed Identifier
20424229
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
23365490
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.
Results Reference
background
PubMed Identifier
17197559
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.
Results Reference
background
Learn more about this trial
Ozurdex in Reducing PVR After Vitreotomy in PDR
We'll reach out to this number within 24 hrs