Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Mean Change in Pain Scores
Study Overview
Brief Summary
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.
Detailed 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 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The patient and the survey administrator are masked to the treatment assignment in each eye.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- •Patients diagnosed with neovascular AMD, DME or macular edema secondary to RVO undergoing anti-VEGF injections in both eyes.
- •> 18 years old
- •Able to provide signed written consent prior to participation in any study-related procedures.
Exclusion Criteria
- •A patient who meets any of the following criteria will be excluded from the study:
- •Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21 days prior to Screening and throughout the study period (systemic mast cell stabilizers are allowed, and systemic antihistamines are permitted)
- •Use of any topical prescription ophthalmic medications (including cyclosporine [Restasis®, Cequa®] or topical lifitegrast [Xiidra®], steroids, nonsteroidal anti- inflammatory drugs [NSAIDs]within 7 days or during study period
- •Participation in any drug or device clinical investigation within 30 days prior to study entry and/or during the study period.
- •Anterior chamber cells present at time of enrollment
- •History of cauterization of the punctum
- •Any punctum inflammation or dacryocystitis
Arms & Interventions
Dextenza
Dextenza (Dexamethasone Ophthalmic Insert 0.4 mg)
Intervention: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Topical Corticosteroids
Topical corticosteroids (prednisolone acetate 1%) QID tapered over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week).
Intervention: Prednisolone Acetate (Drug)
Outcomes
Primary Outcomes
Mean Change in Pain Scores
Time Frame: As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3
As measured by a 10-point standardized pain scale (1 = no pain, 10 = worst pain)
Secondary Outcomes
- Correlation of pain scale outcomes with absence or presence of AC cell count and flare scores(Assessed at 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3)
- Overall Proportion of Eyes with Absence of AC Cell/Flare (Score of 0)(Assessed 3-6 days following Injection Visit 1, Injection Visit 2, and Injection Visit 3)
- Proportion of eyes with absence of AC cells/flare (score of 0)(Assessed at 3-6 days following Injection Visit 1, Injection Visit 2, and Injection Visit 3 by anti-VEGF type (ranibizumab, aflibercept, brolucizumab, or bevacizumab))
- Patient Comfort(As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3)
- Mean Change in Snellen and Pinhole Acuity(As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, and Injection Visit 3, and the Final Post-Injection Follow-up Visit (up to 24 weeks))
- Patient Preference(As assessed at the Final Post-Injection Follow-up Visit (up to 24 weeks))
- Incidence and severity of adverse events(As assessed at Baseline, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3, and the Final Post-Injection Follow-up Visit (up to 24 weeks))
- Mean Change in pain scores(As assessed at Baseline Visit, 6 hours (+/- 2 hours), 24 hours (+/- 3 hours), and at 3-6 days after Injection Visit 1, Injection Visit 2, and Injection Visit 3)
- Mean Change in Tear Break-up Time(As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, Injection Visit 3, and the Final Post-Injection Follow-up Visit (up to 24 weeks))
- Mean change in IOP(As assessed at Baseline Visit, Injection Visit 1, Injection Visit 2, and Injection Visit 3, and the Final Post-Injection Follow-up Visit (up to 24 weeks))
Investigators
David Eichenbaum
Principal Investigator
Retina Vitreous Associates of Florida