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

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Patrick R. Oellers, MD
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Prednisolone

Criteria

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 Criteria:

• 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.