Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

Midwest Eye Institute

Status and phase: Terminated; Phase 4

Conditions: Retinal Detachment

Treatments: Drug: Dextenza; Drug: Prednisolone Acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04464629

The FINNEN Study

Details and patient eligibility

About

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.

Full description

Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pseudophakic
• Retinal Detachment
• Age 18 years and older
• Scheduled for gas bubble repair and laser surgery following retinal detachment
• 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 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
• Patients being treated with immunomodulating agents in the study eye(s)
• Patients 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: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Intracanalicular Sustained Release Dexamethasone, 0.4 mg

Experimental group

Description:

Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery.

Treatment:

Drug: Dextenza

topical prednisolone acetate 1%.

Active Comparator group

Treatment:

Drug: Prednisolone Acetate