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.

Sponsor
Kovach Eye Institute (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04501367
Collaborator
(none)
60
3
18.3

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone Intracanalicular Insert, 0.4 mg
  • Drug: Dexamethasone Intracanalicular Insert, 0.4 mg
  • Drug: Prednisone acetate 1%
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Aug 20, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

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

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 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

Outcome Measures

Primary Outcome Measures

  1. Mean change in retina edema [assessed on day 30 and day 60]

    As measured by Optical Coherence Tomography (OCT)

Secondary Outcome Measures

  1. Mean change in Inflammation ( Cell and Flare) [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

  2. Mean change in pain scores [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

  3. Mean Change in Best- Corrected Visual Acuity (BCVA) [from baseline at days 1, 7, 30, 60]

    as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart

  4. Physician ease of Dextenza insertion [as assessed on day of surgery]

    measured by a 0-10 scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kovach Eye Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kovach Eye Institute
ClinicalTrials.gov Identifier:
NCT04501367
Other Study ID Numbers:
  • Kovacheye
First Posted:
Aug 6, 2020
Last Update Posted:
Aug 6, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2020