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

Retinal Detachment Clinical Trial

Official title:

Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04464629
• Other study ID #: The FINNEN Study
• Status: Terminated
• Phase: Phase 4
• Start date: July 14, 2020
• Est. completion date: January 25, 2023

Study information

• Verified date: August 2023
• Source: Midwest Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Drug:
• Dextenza
Intracanalicular sustained release dexamethasone insert 0.4 mg
• Prednisolone Acetate
Topical Prednisolone acetate 1% ophthalmic suspension

Locations

Country	Name	City	State
United States	Midwest Eye Institute	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Midwest Eye Institute	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in pain score	Average change in pain based on whats reported on the Ocular Pain Assessment	30 Days
Primary	Post-op pain scores	Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.	30 Days
Secondary	Mean change in anterior chamber cell and flare score	Post op inflammation scores as measured on a scale of 0-4: Anterior Chamber Cell Count (Absence of cell to be defined as a grade of: 0-0.5, 4 being the maximum) and Anterior Chamber Flare Score (0 is the minimum, and 4 is the maximum). High reported cell and flare means a worse outcome.	30 days
Secondary	Cystoid Macular Edema	Amount of central thickness macular swelling as measured by Optical Coherence Tomography (OCT)	30 days
Secondary	Best Corrected Visual Acuity	As measured on ETDRS	90 days
Secondary	Physician Ease of Dextenza insertion	The investigator will grade the level of ease of insertion of the intracanalicular insert on a 0 to 10-point (0 being the minimum and 10 being the maximum) scale with 0 being very easy insertion and 10 being very hard. Difficult insertion means a worse outcome.	Day 1