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.

Vitrectomy Clinical Trial

Official title:

Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501367
• Other study ID #: Kovacheye
• Status: Recruiting
• Phase: Phase 4
• Start date: April 27, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Kovach Eye Institute
• Contact: Saad Ahmad, MD
• Phone: 6308339361
• Email: ifixretinas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Epiretinal Membrane
• Inflammation
• Macular Edema
• Macular Pucker
• Papilledema
• Retinal Edema
• Vitrectomy

Intervention

Drug:
• Dexamethasone Intracanalicular Insert, 0.4 mg
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
• Dexamethasone Intracanalicular Insert, 0.4 mg
To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
• Prednisone acetate 1%
To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery

Locations

Country	Name	City	State
United States	Kovach Eye Institute	Elmhurst	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Kovach Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in retina edema	As measured by Optical Coherence Tomography (OCT)	assessed on day 30 and day 60
Secondary	Mean change in Inflammation ( Cell and Flare)	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	as assessed on days 1, 7, 30, 60
Secondary	Mean change in pain scores	as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible	as assessed on days 1, 7, 30, 60
Secondary	Mean Change in Best- Corrected Visual Acuity (BCVA)	as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart	from baseline at days 1, 7, 30, 60
Secondary	Physician ease of Dextenza insertion	measured by a 0-10 scale	as assessed on day of surgery