Dextenza in the Post-op Management of Vitreoretinal Surgeries

NeuroTherapia, Inc.

Status and phase: Enrolling; Phase 4

Conditions: Vitreoretinal Surgery; Post-operative Pain; Post-Operative Inflammation; Ocular Inflammation

Treatments: Drug: Prednisolone Acetate 1% Oph Susp; Drug: Dexamethasone Ophthalmic Insert

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04371445

4-29-2020

Details and patient eligibility

About

This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group.

Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Full description

Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days.

The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women >18 years old
• Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Exclusion criteria

• Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system
• History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye
• Structural lid abnormalities such as ectropion or entropion in surgical eye
• Ongoing use of systemic narcotic pain relievers
• Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline
• Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline
• Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes
• Other ocular surgeries or procedures during the study period and/or 6 months prior
• Intraoperative complications
• Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled.
• Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.
• Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery.
• Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.
• Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure
• Are pregnant or nursing/lactating
• Participation as a subject in any clinical study within the 30 days prior to randomization.
• Surgeries using 20 gauge or 23 gauge instruments.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Intracanalicular dexamethasone insert group

Experimental group

Description:

This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery.

Treatment:

Drug: Dexamethasone Ophthalmic Insert

Topical steroid drop group

Active Comparator group

Description:

This arm will receive the prescription for daily prednisolone acetate 1% eye drops 4 times a day for the first week following the procedure, starting on the day of surgery.

Treatment:

Drug: Prednisolone Acetate 1% Oph Susp