Ozurdex in Reducing PVR After Vitreotomy in PDR

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05415826
• Other study ID #: PKUPHoph
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: June 2022
• Source: Peking University People's Hospital
• Contact: Jinfeng Qu, MD
• Phone: +861088326666
• Email: Jinfeng_QuPKU[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & Publications (9)

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. — View 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. Review. — View 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. Erratum in: Arch Ophthalmol 1990 Oct;108(10):1452. — View 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. — View 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. Epub 2004 Jul 17. — View 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. Review. — View 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. — View 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. — View Citation

Vujosevic S, Simó 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PVR	proliferative vitreoretinopathy after sugery	during 3 months after surgery
Primary	CRT	central retina thickness	from preoperation to 3 months follow-up
Secondary	BCVA	best corrected visual acuity	from preoperation to 3 months follow-up
Secondary	Intraretinal hemorrhage	Intraretinal hemorrhage	during 3 months after surgery