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Retrospective study to provide clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.
This retrospective study is intended to provide large-scale, real-world data on clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXYCU (dexamethasone intraocular suspension) 9%. | DEXYCU (dexamethasone intraocular suspension) 9%. Single dose, intraocularly in the posterior chamber at the end of surgery. The dose is 0.005 mL of dexamethasone 9% (equivalent to 517 micrograms). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEXYCU (dexamethasone intraocular suspension) 9%. | Drug | DEXYCU contains dexamethasone 9% w/w (103.4 mg/mL) as a sterile suspension for intraocular ophthalmic administration. DEXYCU is provided as a kit for administration of a single dose of 0.005 mL of 9% dexamethasone (equivalent to 517 micrograms of dexamethasone). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Anterior Chamber Cell Grade 0 | Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam. | Postoperative day 8 |
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Inclusion Criteria
Exclusion Criteria
• Subjects who underwent cataract surgery and did not receive DEXYCU
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Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU
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| Name | Affiliation | Role |
|---|---|---|
| Dario Paggiarino, MD | Senior Vice President, Chief Medical Officer, EyePoint Pharmaceuticals | Principal Investigator |
| Keyur Patel, PharmD | Vice President, Medical Affairs, EyePoint Pharmaceuticals | Study Chair |
| Flavio Leonin, Jr., MD | Senior Manager, Clinical Affairs, EyePoint Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center South Locations | Dothan | Alabama | 36301 | United States | ||
| Inland Eye Specialists |
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| ID | Title | Description |
|---|---|---|
| FG000 | DEXYCU (Dexamethasone Intraocular Suspension) 9% | All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2019 |
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|
|
| Hemet |
| California |
| 92545 |
| United States |
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States |
| Coastal Vision Medical Group | Orange | California | 92868 | United States |
| North Bay Eye Associates, Inc. | Rohnert Park | California | 94928 | United States |
| The Eye Associates of Manatee, LLP | Bradenton | Florida | 34209 | United States |
| Eye Physicians of Pinellas, PA, dba The Eye Institute of West Florida | Largo | Florida | 33770 | United States |
| Jacksoneye, SC | Lake Villa | Illinois | 60046 | United States |
| Hauser-Ross Eye Institute | Oak Brook | Illinois | 60523 | United States |
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| Physicians Eyecare Center | Baltimore | Maryland | 21229 | United States |
| Discover Vision Centers | Independence | Missouri | 64055 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Surgery Center of Central New Jersey | Pennington | New Jersey | 08534 | United States |
| SightMD, PLLC | Hauppauge | New York | 11788 | United States |
| New York Eye Surgery Center | The Bronx | New York | 10469 | United States |
| Island Eye Surgicenter | Westbury | New York | 11590 | United States |
| Wills Surgery Center | Jenkintown | Pennsylvania | 19046 | United States |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| The Eye Centers of Racine and Kenosha | Racine | Wisconsin | 53405 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
| ID | Title | Description |
|---|---|---|
| BG000 | DEXYCU (Dexamethasone Intraocular Suspension) 9% | All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery. |
| Units | Counts |
|---|---|
| Participants |
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| eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Eyes With Anterior Chamber Cell Grade 0 | Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam. | eyes with a record at postoperative day 8 | Posted | Number | percentage of eyes | Postoperative day 8 | eyes | eyes |
|
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This was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DEXYCU (Dexamethasone Intraocular Suspension) 9% | All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery. | 0 | 527 | 0 | 527 | 20 | 527 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Investigations | Non-systematic Assessment |
| ||
| Corneal edema | Eye disorders | Non-systematic Assessment |
| ||
| Iritis | Eye disorders | Non-systematic Assessment |
| ||
| DEXYCU on lens optic | Product Issues | Non-systematic Assessment |
| ||
| Vision blurred | Eye disorders | Non-systematic Assessment |
| ||
| Retina peripheral hole | Eye disorders | Non-systematic Assessment |
| ||
| Hypotony maculopathy | Eye disorders | Non-systematic Assessment |
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| Retained cortex in anterior chamber | Eye disorders | Non-systematic Assessment |
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During the Study and for a period of ten (10) years after completion or early termination of the Multi-Center Retrospective Trial, without Sponsor's and/or its representative prior written consent, Institution and Investigator will not publish, disseminate or otherwise disclose, deliver or make available any Confidential Information to any third party other than Study Personnel or Sponsor's representative, and then only for the purpose of conducting the Study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dario Paggiarino, MD | EyePoint Pharmaceuticals | (617) 610-3411 | dpaggiarino@eyepointpharma.com |
| May 24, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| 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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| Not Reported |
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| Unknown |
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