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.

Phase 4

Recruiting

• Conditions: Vitrectomy; Macular Pucker; Retinal Edema
• Interventions: Drug: Dexamethasone Intracanalicular Insert, 0.4 mg; Drug: Prednisone acetate 1%

• Registration Number: NCT04501367
• Lead Sponsor: Kovach Eye Institute

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Study Start: 2021-04-27
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Second DEXTENZA Group	Dexamethasone Intracanalicular Insert, 0.4 mg	Patients undergoing vitrectomy with internal limiting membrane peel
Topical Prednisolone Acetate 1% Group	Prednisone acetate 1%	Patients undergoing vitrectomy with internal limiting membrane peel
DEXTENZA Group	Dexamethasone Intracanalicular Insert, 0.4 mg	Patients undergoing vitrectomy with internal limiting membrane peel

Primary Outcome Measures

Name	Time	Method
Mean change in retina edema	assessed on day 30 and day 60	As measured by Optical Coherence Tomography (OCT)

Secondary Outcome Measures

Name	Time	Method
Mean Change in Best- Corrected Visual Acuity (BCVA)	from baseline at days 1, 7, 30, 60	as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart
Physician ease of Dextenza insertion	as assessed on day of surgery	measured by a 0-10 scale
Mean change in Inflammation ( Cell and Flare)	as assessed on days 1, 7, 30, 60	As measured by SUN (Standardization of Uveitis Nomenclature) grading scale;absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of 0-1
Mean change in pain scores	as assessed on days 1, 7, 30, 60	as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible

Trial Locations

Locations (1)

Kovach Eye Institute; 🇺🇸 Elmhurst, Illinois, United States