Trial | NCT04501367  Report issue

Title

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.
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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    60
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
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 Started
Apr 27
2021
Primary Completion
Dec 31
2024
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Jun 29
2023

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

Drug 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

Drug Prednisone acetate 1%

To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery

DEXTENZA Group Experimental

Patients undergoing vitrectomy with internal limiting membrane peel

Second DEXTENZA Group Experimental

Patients undergoing vitrectomy with internal limiting membrane peel

Topical Prednisolone Acetate 1% Group Experimental

Patients undergoing vitrectomy with internal limiting membrane peel

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
No Results Posted