Status:
COMPLETED
DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery
Lead Sponsor:
Patrick R. Oellers, MD
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Vitreo-Retinal Surgery
Eligibility:
All Genders
Phase:
PHASE4
Brief 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
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04462523
Start Date
January 3 2020
End Date
March 31 2022
Last Update
June 15 2023
Active Locations (1)
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1
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, United States, 13088