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

NCT ID: NCT04462523

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-03
• Study Completion Date: 2022-03-31

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 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.

Conditions

Vitreo-Retinal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Topical Prednisolone

Intervention Type: DRUG

Standard of care topical drop treatment

Interventions

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.

Intervention Type: DRUG

Topical Prednisolone

Standard of care topical drop treatment

Intervention Type: DRUG

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role: collaborator

Patrick R. Oellers, MD

NETWORK

Sponsor Role: lead

Responsible Party

Patrick R. Oellers, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Retina Vitreous Surgeons of Central New York, PC

Liverpool, New York, United States

Countries

United States

References

Ueberroth JA, Oellers PR, Brown J, Rosenberg KI, Breazzano MP. Intracanalicular Dexamethasome Insert after Retinal Surgery: the ADHERE Trial. Ophthalmol Retina. 2023 Sep;7(9):831-833. doi: 10.1016/j.oret.2023.06.011. Epub 2023 Jun 24. No abstract available.

Reference Type: DERIVED

PMID: 37356492 (View on PubMed)

Other Identifiers

The ADHERE Study

Identifier Type: -

Identifier Source: org_study_id