Clinical trial NCT04501367: 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.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitrectomy
Macular Pucker
Retinal Edema
Lead sponsor: Kovach Eye Institute
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In patients who undergo vitrectomy with internal limiting membrane peel surgery , subjects will be randomized to three groups and be followed for a period of two months. One group will be selected to receive one DEXTENZA (in the lower canaliculus), the second group will receive two DEXTENZA (upper and lower canaliculi) and the third group will receive prednisolone acetate 1% (control eye) . All groups will receive a subconjunctival dexamethasone injection at the time of surgery.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in retina edema
timeFrame: assessed on day 30 and day 60
Secondary outcomes:
measure: Mean change in Inflammation ( Cell and Flare)
timeFrame: as assessed on days 1, 7, 30, 60
measure: Mean change in pain scores
timeFrame: as assessed on days 1, 7, 30, 60
measure: Mean Change in Best- Corrected Visual Acuity (BCVA)
timeFrame: from baseline at days 1, 7, 30, 60
measure: Physician ease of Dextenza insertion
timeFrame: as assessed on day of surgery
Other outcomes:
Locations:
city: Elmhurst
country: United States
facility: Kovach Eye Institute
state: Illinois
Study officials:
affiliation: Kovach Eye Institute
name: Saad Ahmad, MD
role: PRINCIPAL_INVESTIGATOR
References: