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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.

Primary Purpose

Vitrectomy, Macular Pucker, Retinal Edema

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Intracanalicular Insert, 0.4 mg
Dexamethasone Intracanalicular Insert, 0.4 mg
Prednisone acetate 1%
Sponsored by
Kovach Eye Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kovach Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

DEXTENZA Group

Second DEXTENZA Group

Topical Prednisolone Acetate 1% Group

Arm Description

Patients undergoing vitrectomy with internal limiting membrane peel

Patients undergoing vitrectomy with internal limiting membrane peel

Patients undergoing vitrectomy with internal limiting membrane peel

Outcomes

Primary Outcome Measures

Mean change in retina edema
As measured by Optical Coherence Tomography (OCT)

Secondary Outcome Measures

Mean change in Inflammation ( Cell and Flare)
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
Mean change in pain scores
as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible
Mean Change in Best- Corrected Visual Acuity (BCVA)
as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart
Physician ease of Dextenza insertion
measured by a 0-10 scale

Full Information

First Posted
July 30, 2020
Last Updated
June 27, 2023
Sponsor
Kovach Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04501367
Brief Title
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.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kovach Eye Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitrectomy, Macular Pucker, Retinal Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
In patients who undergo vitrectomy with internal limiting membrane peel surgery , subjects will be randomized to three groups and be followed for a period of two months. One group will be selected to receive one DEXTENZA (in the lower canaliculus), the second group will receive two DEXTENZA (upper and lower canaliculi) and the third group will receive prednisolone acetate 1% (control eye) . All groups will receive a subconjunctival dexamethasone injection at the time of surgery.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEXTENZA Group
Arm Type
Experimental
Arm Description
Patients undergoing vitrectomy with internal limiting membrane peel
Arm Title
Second DEXTENZA Group
Arm Type
Experimental
Arm Description
Patients undergoing vitrectomy with internal limiting membrane peel
Arm Title
Topical Prednisolone Acetate 1% Group
Arm Type
Experimental
Arm Description
Patients undergoing vitrectomy with internal limiting membrane peel
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Intracanalicular Insert, 0.4 mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Intracanalicular Insert, 0.4 mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisone acetate 1%
Intervention Description
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery
Primary Outcome Measure Information:
Title
Mean change in retina edema
Description
As measured by Optical Coherence Tomography (OCT)
Time Frame
assessed on day 30 and day 60
Secondary Outcome Measure Information:
Title
Mean change in Inflammation ( Cell and Flare)
Description
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
Time Frame
as assessed on days 1, 7, 30, 60
Title
Mean change in pain scores
Description
as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible
Time Frame
as assessed on days 1, 7, 30, 60
Title
Mean Change in Best- Corrected Visual Acuity (BCVA)
Description
as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart
Time Frame
from baseline at days 1, 7, 30, 60
Title
Physician ease of Dextenza insertion
Description
measured by a 0-10 scale
Time Frame
as assessed on day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saad Ahmad, MD
Phone
6308339361
Email
ifixretinas@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie White, Bachelors
Phone
6308339621
Email
jamie.white@kovacheye.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Ahmad, MD
Organizational Affiliation
Kovach Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kovach Eye Institute
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie White, BA
Phone
630-833-9361
Ext
129
Email
jamie.white@kovacheye.com
First Name & Middle Initial & Last Name & Degree
Saad Ahmad, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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