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

NCT04462523 | Completed Phase 4 FDA Drug

• 1 other identifier: The ADHERE Study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Vitreo-Retinal Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Mean anterior chamber flare

  Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56

• Time to absence of cells

  Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56

• Time to absence of pain

  Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56

• Proportion of rescue treatment

  Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56

• Assessment of Dextenza ease of insertion

  Assessed at Day 1

Study Arms (4)

Group 1 Pre-surgery Dextenza insert

EXPERIMENTAL

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

Group 2 Surgery Day Dextenza insert

EXPERIMENTAL

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

Group 3 Post op Day 1 Dextenza insert

EXPERIMENTAL

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

Group 4 Topical steroid

ACTIVE COMPARATOR

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

Interventions

Dextenza 0.4Mg Ophthalmic Insert 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 1 Pre-surgery Dextenza insert; Group 2 Surgery Day Dextenza insert; Group 3 Post op Day 1 Dextenza insert

Topical Prednisolone DRUG

Standard of care topical drop treatment

Group 4 Topical steroid

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Patrick R. Oellers, MD: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Retina Vitreous Surgeons of Central New York, PC

Liverpool, New York, 13088, United States

Location

Related Publications (1)

• 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.

  PMID: 37356492 DERIVED

MeSH Terms

Interventions

Calcium Dobesilate; Prednisolone

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masked Sub-investigators to exam subjects at each visit after clinical evaluation for cell and/or flare.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 8, 2020
• Study Start: January 3, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (1)