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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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The purpose of this study is to evaluate efficacy and safety of Dextenza for the treatment of postoperative pain and inflammation following vitreo-retinal surgery
This prospective, single-center, open-label, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing vitro-retinal surgery with the treatment of a dexamethasone intracanalicular insert. All patients in the treatment groups will receive a dexamethasone intracanalicular insert. There will be three experimental groups of patients, varying that time of insertion. Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. Ten patients will receive DEXTENZA insert Day 1 post-operatively. Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Pre-surgery Dextenza insert | Experimental | Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops. |
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| Group 2 Surgery Day Dextenza insert | Experimental | Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops. |
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| Group 3 Post op Day 1 Dextenza insert | Experimental | Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops |
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| Group 4 Topical steroid | Active Comparator | Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insert | Drug | The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean cells as assessed by investigator in anterior chamber of the study eye | As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+) | Assessed at Day 14 |
| Mean pain as reported by subject in the study eye: Visual Analog Scale | As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale) | Assessed at Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean anterior chamber flare | As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+) | Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56 |
| Time to absence of cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Vitreous Surgeons of Central New York, PC | Liverpool | New York | 13088 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37356492 | Derived | Ueberroth JA, Oellers PR, Brown J, Rosenberg KI, Breazzano MP. Intracanalicular Dexamethasome Insert after Retinal Surgery: the ADHERE Trial. Ophthalmol Retina. 2023 Sep;7(9):831-833. doi: 10.1016/j.oret.2023.06.011. Epub 2023 Jun 24. No abstract available. |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Masked Sub-investigators to exam subjects at each visit after clinical evaluation for cell and/or flare.
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| Topical Prednisolone | Drug | Standard of care topical drop treatment |
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As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
| Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56 |
| Time to absence of pain | As measure by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale) | Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56 |
| Proportion of rescue treatment | As measure by Concomitant Medications as rescue therapy | Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56 |
| Assessment of Dextenza ease of insertion | As measured by Ease of Use Survey (0=very easy to 10=very hard) | Assessed at Day 1 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |