Status:
UNKNOWN
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.
Lead Sponsor:
Kovach Eye Institute
Conditions:
Vitrectomy
Macular Pucker
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04501367
Start Date
April 27 2021
End Date
December 31 2024
Last Update
June 29 2023
Active Locations (1)
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1
Kovach Eye Institute
Elmhurst, Illinois, United States, 60126