Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Macular Edema
- Neovascular Age Related Macular Degeneration
- Retinal Vein Occlusion
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Within the respective cohorts, one eye per patient will be randomized to receive either an intracanalicular dexamethasone insert or the control treatment at each injection visit.Masking: Double (Participant, Outcomes Assessor)Masking Description: The patient and the survey administrator are masked to the treatment assignment in each eye.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Patients will be randomized into two cohorts (Cohort 1 and Cohort 2) and then followed for 3 consecutive injecti...
This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Patients will be randomized into two cohorts (Cohort 1 and Cohort 2) and then followed for 3 consecutive injection visits. Treatment will be rendered at each injection visit based on the individualized routine established anti-VEGF injection interval for each patient. Within the respective cohorts, one eye per patient will be randomized to receive either an intracanalicular dexamethasone insert or the control treatment at each injection visit. Cohorts are as follows: Cohort 1: Total N= 40 eyes (20 patients). Twenty eyes (one eye per patient) will be randomized to receive an intracanalicular dexamethasone insert. The contra-lateral eye (Control) will receive a sham dilation. Cohort 2: Total N= 40 eyes (20 patients). Twenty eyes (one eye per patient) will be randomized to receive an intracanalicular dexamethasone insert. The contra-lateral eye (Control) will receive topical corticosteroids (prednisolone acetate 1%) QID tapered over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week). In eyes randomized to either DEXTENZA or sham dilation, DEXTENZA insertion or sham dilation will be performed prior to injection. In eyes randomized to either DEXTNEZA or topical steroids, eyes randomized to DEXTENZA will receive insertion prior to injection. Eyes randomized to topical steroid therapy (Control) will receive 1 drop of prednisolone acetate 1% pre-injection and the remaining 3 drops of prednisolone acetate 1% post injection. Control eyes will follow tapered dosing over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week) to ensure dose matching between DEXTENZA and Control in Cohort 1. Pain will be rated at 6 time points: (1) prior to any treatment, (2) after anesthesia, (3) after intravitreal injection, (4) 6 hours by telephone (+/- 2 hours), (5) 24 hours by telephone (+/-3 hours) and (6) 3-6 days at assessment visit. Pain will be evaluated by survey administrators masked to treatment assignment. Patient comfort (right eye vs left eye) will be assessed at each patient visit by masked survey administrator. Anterior cell count and anterior cell flare assessment will be conducted at 3-6 days following each intravitreal injection visit. There will be a final patient preference survey performed.
Tracking Information
- NCT #
- NCT04563299
- Collaborators
- Ocular Therapeutix, Inc.
- Investigators
- Principal Investigator: David Eichenbaum, MD Retina Vitreous Associates of Florida