NCT05415826

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 8, 2022

Last Update Submit

June 8, 2022

Conditions

Diabetic Retinopathy

Keywords

PDR; PVR; Ozurdex

Outcome Measures

Primary Outcomes (2)

  • PVR

    proliferative vitreoretinopathy after sugery

    during 3 months after surgery

  • CRT

    central retina thickness

    from preoperation to 3 months follow-up

Secondary Outcomes (2)

  • BCVA

    from preoperation to 3 months follow-up

  • Intraretinal hemorrhage

    during 3 months after surgery

Study Arms (2)

PPV group

ACTIVE COMPARATOR

Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling.

Procedure: slow-release dexamethasone implant

PPV+implant group

EXPERIMENTAL

Eyes with proliferative diabetic retinopathy underwent PPV surgery with silicone oil filling and slow-release dexamethasone implant.

Procedure: slow-release dexamethasone implant

Interventions

slow-release dexamethasone implantPROCEDURE

The eyes with proliferative diabetic retinopathy underwent PPV with silicone oil filling with or without slow-release dexamethasone implant at the end of surgery.

PPV groupPPV+implant group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 9627648BACKGROUND

  • 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.

    PMID: 10030553BACKGROUND

  • 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.

    PMID: 2196036BACKGROUND

  • 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.

    PMID: 28510630BACKGROUND

  • 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.

    PMID: 15258777BACKGROUND

  • 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.

    PMID: 20424229BACKGROUND

  • 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.

    PMID: 19509100BACKGROUND

  • 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.

    PMID: 23365490BACKGROUND

  • 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.

    PMID: 17197559BACKGROUND

MeSH Terms

Conditions

Diabetic RetinopathyVitreoretinopathy, Proliferative

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Jinfeng Qu, MD

    Peking University People's Hospital

    STUDY CHAIR

Central Study Contacts

Jinfeng Qu, MD

CONTACT

+861088326666Jinfeng_QuPKU@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 13, 2022

Study Start

June 15, 2022

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share