DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery

Last updated: June 14, 2023
Sponsor: Patrick R. Oellers, MD
Overall Status: Completed

Phase

4

Condition

Inflammation

Treatment

Topical Prednisolone

Dextenza 0.4Mg Ophthalmic Insert

Clinical Study ID

NCT04462523
The ADHERE Study
  • All Genders

Study Summary

The purpose of this study is to evaluate efficacy and safety of Dextenza for the treatment of postoperative pain and inflammation following vitreo-retinal surgery

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any adult patient age 18-99 years who is planned to undergo vitreo-retinal surgery (pars plana vitrectomy with or without scleral buckle).
  • If both eyes are involved, both eyes would be eligible for the study.
  • Willing and able to comply with clinic visits and study related procedures.
  • Willing and able to sign the informed consent form.

Exclusion

Exclusion Criteria:

  • Patients under age 18.
  • Patients who are pregnant (must be ruled out in women of child-bearing age withpregnancy test).
  • Active infectious ocular or systemic disease.
  • Patients with active infectious ocular or extraocular disease.
  • Patients actively treated with local or systemic immunosuppression
  • Use of the following anti-inflammatory or immunomodulating agents (e.g., cyclosporine)systemically, or in the study eye, for the duration of the study (excludinginhalants). Washout periods for medications prior to surgery are as follows:
  • Systemic corticosteroids - 2 weeks (see exception 5c)
  • Systemic NSAID over 375 mg per day - 2 weeks
  • Periocular/intraocular injection of any corticosteroid solution - 4 weeks (seeexception 5b)
  • Corticosteroid depot/implant in the study eye - 2 months
  • Topical ocular corticosteroid - 7 days
  • Topical ocular NSAID - 7 days
  • Intraoperatively used intraocular steroid (i.e. intravitreal triamcinolone, that isused to transiently highlight the vitreous and removed during vitrectomy) ispermissible in study eye.
  • Intraoperatively or perioperatively used systemic steroid for the purpose of generalanesthesia (as administered by the treating anesthesiologist) is permissible.
  • Patients with systemic illness involving abnormalities of thehypothalamic-pituitary-adrenal axis; patients with primary adrenocorticalinsufficiency or adrenocortical hyperfunction.
  • Patients with known hypersensitivity to Dexamethasone.
  • Patients with uncontrolled glaucoma.
  • Patients with severe disease that warrants critical attention, deemed unsafe for thestudy by the investigator.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Topical Prednisolone
Phase: 4
Study Start date:
January 03, 2020
Estimated Completion Date:
March 31, 2022

Study Description

This prospective, single-center, open-label, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing vitro-retinal surgery with the treatment of a dexamethasone intracanalicular insert. All patients in the treatment groups will receive a dexamethasone intracanalicular insert. There will be three experimental groups of patients, varying that time of insertion. Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. Ten patients will receive DEXTENZA insert Day 1 post-operatively. Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.

Connect with a study center

  • Retina Vitreous Surgeons of Central New York, PC

    Liverpool, New York 13088
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.