Recruiting

Dextenza

Sponsor:

Kovach Eye Institute

Code:

NCT04501367

Conditions

Vitrectomy

Macular Pucker

Retinal Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone Intracanalicular Insert, 0.4 mg

Dexamethasone Intracanalicular Insert, 0.4 mg

Prednisone acetate 1%

Study Details

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

Conditions

Vitrectomy

Macular Pucker

Retinal Edema

Study ID

NCT04501367

Start date

Apr 27, 2021

Status verified date

Jun, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DEXTENZA Group

Patients undergoing vitrectomy with internal limiting membrane peel

experimental: Second DEXTENZA Group

Patients undergoing vitrectomy with internal limiting membrane peel

experimental: Topical Prednisolone Acetate 1% Group

Patients undergoing vitrectomy with internal limiting membrane peel

Interventions

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

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

Prednisone acetate 1%

To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery

Primary outcome measure

  • Mean change in retina edema [ Time Frame: assessed on day 30 and day 60 ]

Central Contacts and Locations

Central contacts

Saad Ahmad, MD

6308339361ifixretinas@gmail.com

Jamie White, Bachelors

6308339621jamie.white@kovacheye.com

Locations

Kovach Eye Institute

Recruiting

Elmhurst, Illinois, United States, 60126

Contacts

Jamie White, BA

630-833-9361jamie.white@kovacheye.com

Principal Investigator:

Saad Ahmad, MD

More Information

Sponsor

Kovach Eye Institute

Last update posted

Jun 29, 2023

Last verified

Jun, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kovach Eye Institute on 2023-06-29.