Title
DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery
Open-label, Single -Center, Prospective Study on the Efficacy and Safety of Intracanalicular Dexamethasone Insert 0.4mg (Dextenza) in the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery - The ADHERE Study
Phase
Phase 4Lead Sponsor
Retina Vitreous Surgeons of Central New York, PCStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Vitreo-Retinal SurgeryIntervention/Treatment
Dextenza 0.4Mg Ophthalmic Insert Topical PrednisoloneStudy Participants
40The purpose of this study is to evaluate efficacy and safety of Dextenza for the treatment of postoperative pain and inflammation following vitreo-retinal surgery
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.
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Standard of care topical drop treatment
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.
Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops
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.
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.
