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

Patrick R. Oellers, MD

Status and phase: Completed; Phase 4

Conditions: Vitreo-Retinal Surgery

Treatments: Drug: Topical Prednisolone; Drug: Dextenza 0.4Mg Ophthalmic Insert

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04462523

The ADHERE Study

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Group 1 Pre-surgery Dextenza insert

Experimental group

Description:

Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert

Group 2 Surgery Day Dextenza insert

Experimental group

Description:

Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert

Group 3 Post op Day 1 Dextenza insert

Experimental group

Description:

Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert

Group 4 Topical steroid

Active Comparator group

Description:

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.

Treatment:

Drug: Topical Prednisolone