Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

Kovach Eye Institute (KEI)

Status and phase: Enrolling; Phase 4

Conditions: Vitrectomy; Macular Pucker; Retinal Edema

Treatments: Drug: Dexamethasone Intracanalicular Insert, 0.4 mg; Drug: Prednisone acetate 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04501367

Kovacheye

Details and patient eligibility

About

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel

Full description

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

• Symptomatic macular pucker with retinal edema
• Age 18 years and older
• Scheduled vitrectomy and internal limiting membrane peel
• Willing and able to comply with clinic visits and study related procedures
• Willing and able to sign the informed consent form

Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study:

• Patients under the age of 18
• Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test)
• Active infectious systemic disease
• Active infectious ocular or extraocular disease
• Obstructed nasolacrimal duct in the study eye (s)
• Hypersensitivity to dexamethasone or prednisolone eye drops
• Patients being treated with immunomodulating agents in the study eye(s)
• Patient being treated with immunosuppressants and/or oral steroids
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

DEXTENZA Group

Experimental group

Description:

Patients undergoing vitrectomy with internal limiting membrane peel

Treatment:

Drug: Dexamethasone Intracanalicular Insert, 0.4 mg

Drug: Dexamethasone Intracanalicular Insert, 0.4 mg

Second DEXTENZA Group

Experimental group

Description:

Patients undergoing vitrectomy with internal limiting membrane peel

Treatment:

Drug: Dexamethasone Intracanalicular Insert, 0.4 mg

Drug: Dexamethasone Intracanalicular Insert, 0.4 mg

Topical Prednisolone Acetate 1% Group

Experimental group

Description:

Patients undergoing vitrectomy with internal limiting membrane peel

Treatment:

Drug: Prednisone acetate 1%