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

Completed · Phase 4

Conditions studied: Vitreo-Retinal Surgery

In brief

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

Key facts

Study ID

NCT04462523

Run by

Patrick R. Oellers, MD

People needed

40

Starts

2020-01-03

Expected to finish

2022-03-31

Last updated by the study team

2023-06-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients under age 18.
• Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy 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 (excluding inhalants). 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 (see exception 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 is used to transiently highlight the vitreous and removed during vitrectomy) is permissible in study eye.
• Intraoperatively or perioperatively used systemic steroid for the purpose of general anesthesia (as administered by the treating anesthesiologist) is permissible.
• Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
• Patients with known hypersensitivity to Dexamethasone.
• Patients with uncontrolled glaucoma.
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.

Where it is running

• Retina Vitreous Surgeons of Central New York, PC — Liverpool, New York, United States

Full record on ClinicalTrials.gov

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