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

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

Study Overview

• Status: Completed
• Conditions: Vitreo-Retinal Surgery
• Intervention / Treatment: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Topical Prednisolone

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 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Christine Dorr; Phone Number: 5655 315-445-8166; Email: cdorr@rvscny.com

Study Locations

• United States
  • New York
    • Liverpool, New York, United States, 13088
      • Retina Vitreous Surgeons of Central New York, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Pre-surgery Dextenza insert; 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.	Drug: Dextenza 0.4Mg Ophthalmic Insert; 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.
Experimental: Group 2 Surgery Day Dextenza insert; Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.	Drug: Dextenza 0.4Mg Ophthalmic Insert; 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.
Experimental: Group 3 Post op Day 1 Dextenza insert; Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops	Drug: Dextenza 0.4Mg Ophthalmic Insert; 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.
Active Comparator: Group 4 Topical steroid; 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.	Drug: Topical Prednisolone; Standard of care topical drop treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean cells as assessed by investigator in anterior chamber of the study eye	As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)	Assessed at Day 14
Mean pain as reported by subject in the study eye: Visual Analog Scale	As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)	Assessed at Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean anterior chamber flare	As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)	Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Time to absence of cells	As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)	Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Time to absence of pain	As measure by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)	Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Proportion of rescue treatment	As measure by Concomitant Medications as rescue therapy	Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
Assessment of Dextenza ease of insertion	As measured by Ease of Use Survey (0=very easy to 10=very hard)	Assessed at Day 1

Collaborators and Investigators

• Sponsor: Patrick R. Oellers, MD
• Collaborators: Ocular Therapeutix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Inflammation; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: The ADHERE Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No