Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane

June 9, 2022 updated by: Peking University People's Hospital

Evaluation of Intraoperative Slow-release Dexamethasone Implant Used During Vitrectomy for Epiretinal Membrane

Epiretinal membrane (ERM) is a commonly encountered vitreoretinal interface anomaly with a prevalence of approximately 10% in the adult population. It is often treated with pars plana vitrectomy (PPV) and membrane peeling when symptomatic. PPV is generally successful at improving visual acuity (VA) and/or metamorphopsia. At times, however, visual recovery can be hindered by macular edema in the post-vitrectomy period. Ozurdex can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Small gauge pars plana vitrectomy (PPV) with membrane peeling is used to successfully treat macular epiretinal membranes (ERMs) with a postoperative improvement of visual acuity in the majority of cases. Traditionally, the treatment of ERMs has been performed purely by peeling the membrane mechanically and then waiting for the intraretinal edema to resolve spontaneously. In the last few years, some publications raised the possibility that triamcinolone acetonide (TA),given as an intravitreal injection at the end of surgery, can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. Dexamethasone is a potent synthetic member of the glucocorticoid class of steroid drugs that has anti-inflammatory and immunosuppressant activity 30 times that of cortisol and 6 times that of triamcinolone. As the postoperative cystoid macular edema usually peaks 4 to 6 weeks after surgery the difference in the half life can be significant and explained the results in past publications. While the use of intravitreal TA as an adjuvant to PPV with membrane peel showed conflicting results. Only few publications demonstrated the effectiveness of Ozurdex in the treatment of macular edema in a vitrectomized eye, after ERM removal.So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.

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:

  • patients with a visually significant (BCVA<20/50) idiopathic epiretinal membrane.
  • ocular axial length less than 27.00 mm (optical biometry) associated with cataracts.

Exclusion Criteria:

  • concomitant or previous macular diseases (diabetic macular edema, retinal vein occlusion and agerelated macular degeneration).
  • secondary epiretinal membrane, other visually significant macular pathology and prior intravitreal triamcinolone acetonide injection.

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
Epiretinal membrane eyes underwent PPV
Procedure: slow-release dexamethasone implant
Epiretinal membrane eyes underwent PPV combined with Ozurdex implant
Experimental: PPV+implant Group
Epiretinal membrane eyes underwent PPV combined with Ozurdex implant
Procedure: slow-release dexamethasone implant
Epiretinal membrane eyes underwent PPV combined with Ozurdex implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CMT
Time Frame: from preoperation to 3 months follow-up
central macular thickness
from preoperation to 3 months follow-up
IOP
Time Frame: from preoperation to 3 months follow-up
intraocular pressure
from preoperation to 3 months follow-up
BCVA
Time Frame: from preoperation to 3 months follow-up
best-corrected visual acuity
from preoperation to 3 months follow-up

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 9, 2022

First Submitted That Met QC Criteria

June 9, 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 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPHophthal

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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