Dextenza in the Post-op Management of Vitreoretinal Surgeries

• Status: Enrolling by invitation
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.