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Subject Enrollment
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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextenza | Experimental | Dextenza (Dexamethasone Ophthalmic Insert 0.4 mg) |
|
| Topical Corticosteroids | Active Comparator | Topical corticosteroids (prednisolone acetate 1%) QID tapered over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insert | Drug | All eyes (n=40) will receive anti-VEGF injections for the treatment of AMD, DME and macular edema secondary to RVO. Twenty eyes (one eye per patient) will be randomized to receive Dextenza. The contra-lateral eye (Control) will receive a sham dilation. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Pain Scores | As measured by a 10-point standardized pain scale (1 = no pain, 10 = worst pain) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Proportion of Eyes with Absence of AC Cell/Flare (Score of 0) | As measured using SUN criteria | 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) |
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Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| David Eichenbaum, MD | Retina Vitreous Associates of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711-1141 | United States |
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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.
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The patient and the survey administrator are masked to the treatment assignment in each eye.
|
| Prednisolone Acetate | Drug | All eyes (n=40) will receive anti-VEGF injections for the treatment of AMD, DME and macular edema secondary to RVO. Twenty eyes (one eye per patient) will be randomized to receive Dextenza. 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). |
|
As measured using SUN criteria |
| 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) |
| Correlation of pain scale outcomes with absence or presence of AC cell count and flare scores | As measured using 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 |
| Mean Change in pain scores | As measured by a 10-point standardized pain scale (1 = no pain, 10 = worst pain) | 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 |
| Patient Comfort | As measured by masked survey administrator | 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 measured by the 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 Snellen and Pinhole Acuity | As measured by the ETDRS visual acuity chart | 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) |
| Mean change in IOP | As measured by using a Tono-pen | 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 measured by modified COMTOL | As assessed at the Final Post-Injection Follow-up Visit (up to 24 weeks) |
| Incidence and severity of adverse events | As measured by the 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) |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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