Ozurdex in Reducing PVR After Vitreotomy in PDR

June 8, 2022 updated by: Peking University People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PVR
Time Frame: during 3 months after surgery
proliferative vitreoretinopathy after sugery
during 3 months after surgery
CRT
Time Frame: from preoperation to 3 months follow-up
central retina thickness
from preoperation to 3 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCVA
Time Frame: from preoperation to 3 months follow-up
best corrected visual acuity
from preoperation to 3 months follow-up
Intraretinal hemorrhage
Time Frame: during 3 months after surgery
Intraretinal hemorrhage
during 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Chair: Jinfeng Qu, MD, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2022

Primary Completion (Anticipated)

September 15, 2022

Study Completion (Anticipated)

September 15, 2022

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPHoph

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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