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

NCT ID: NCT04464629

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2023-01-25

Brief Summary

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.

Detailed 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.

Conditions

Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intracanalicular Sustained Release Dexamethasone, 0.4 mg

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.

Group Type: EXPERIMENTAL

Dextenza

Intervention Type: DRUG

Intracanalicular sustained release dexamethasone insert 0.4 mg

topical prednisolone acetate 1%.

Group Type: ACTIVE_COMPARATOR

Prednisolone Acetate

Intervention Type: DRUG

Topical Prednisolone acetate 1% ophthalmic suspension

Interventions

Dextenza

Intracanalicular sustained release dexamethasone insert 0.4 mg

Intervention Type: DRUG

Prednisolone Acetate

Topical Prednisolone acetate 1% ophthalmic suspension

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role: collaborator

Midwest Eye Institute

OTHER

Sponsor Role: lead

Responsible Party

Neil Finnen, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil Finnen, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Medical Advisors, Inc

Locations

Midwest Eye Institute

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

The FINNEN Study

Identifier Type: -

Identifier Source: org_study_id