Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections
- Conditions
- Neovascular Age-related Macular DegenerationRetinal Vein OcclusionDiabetic Macular Edema
- Interventions
- Registration Number
- NCT04563299
- Lead Sponsor
- Retina Vitreous Associates of Florida
- 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:
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dextenza Dextenza 0.4Mg Ophthalmic Insert Dextenza (Dexamethasone Ophthalmic Insert 0.4 mg) Topical Corticosteroids Prednisolone Acetate Topical corticosteroids (prednisolone acetate 1%) QID tapered over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week).
- Primary Outcome Measures
Name Time Method 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 As measured by a 10-point standardized pain scale (1 = no pain, 10 = worst pain)
- Secondary Outcome Measures
Name Time Method 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 As measured using pain scale outcomes with absence or presence of AC cell count and flare scores
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 As measured using SUN criteria
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) As measured using SUN criteria
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 As measured by masked survey administrator
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) As measured by the ETDRS visual acuity chart
Patient Preference As assessed at the Final Post-Injection Follow-up Visit (up to 24 weeks) As measured by modified COMTOL
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) As measured by the incidence and severity of adverse events
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 As measured by a 10-point standardized pain scale (1 = no pain, 10 = worst pain)
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) As measured by the tear break-up time
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) As measured by using a Tono-pen
Trial Locations
- Locations (1)
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States