Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

June 27, 2023 updated by: Kovach Eye Institute

Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

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

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Kovach Eye Institute
        • Contact:
        • Principal Investigator:
          • Saad Ahmad, MD

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

  • Symptomatic macular pucker with retinal edema
  • Age 18 years and older
  • Scheduled vitrectomy and internal limiting membrane peel
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study:

  • Patients under the age of 18
  • Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test)
  • Active infectious systemic disease
  • Active infectious ocular or extraocular disease
  • Obstructed nasolacrimal duct in the study eye (s)
  • Hypersensitivity to dexamethasone or prednisolone eye drops
  • Patients being treated with immunomodulating agents in the study eye(s)
  • Patient being treated with immunosuppressants and/or oral steroids
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEXTENZA Group
Patients undergoing vitrectomy with internal limiting membrane peel
Drug: Dexamethasone Intracanalicular Insert, 0.4 mg
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
Drug: Dexamethasone Intracanalicular Insert, 0.4 mg
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
Experimental: Second DEXTENZA Group
Patients undergoing vitrectomy with internal limiting membrane peel
Drug: Dexamethasone Intracanalicular Insert, 0.4 mg
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
Drug: Dexamethasone Intracanalicular Insert, 0.4 mg
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
Experimental: Topical Prednisolone Acetate 1% Group
Patients undergoing vitrectomy with internal limiting membrane peel
Drug: Prednisone acetate 1%
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in retina edema
Time Frame: assessed on day 30 and day 60
As measured by Optical Coherence Tomography (OCT)
assessed on day 30 and day 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in Inflammation ( Cell and Flare)
Time Frame: as assessed on days 1, 7, 30, 60
As measured by SUN (Standardization of Uveitis Nomenclature) grading scale;absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of 0-1
as assessed on days 1, 7, 30, 60
Mean change in pain scores
Time Frame: as assessed on days 1, 7, 30, 60
as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible
as assessed on days 1, 7, 30, 60
Mean Change in Best- Corrected Visual Acuity (BCVA)
Time Frame: from baseline at days 1, 7, 30, 60
as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart
from baseline at days 1, 7, 30, 60
Physician ease of Dextenza insertion
Time Frame: as assessed on day of surgery
measured by a 0-10 scale
as assessed on day of surgery

Collaborators and Investigators

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

Sponsor

Kovach Eye Institute

Investigators

  • Principal Investigator: Saad Ahmad, MD, Kovach Eye Institute

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 (Actual)

April 27, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kovacheye

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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