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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.
Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant.
Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.59 mg Fluocinolone Acetonide implant | Experimental | 0.59 mg Fluocinolone Acetonide implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.59 mg Fluocinolone Acetonide implant | Drug | 0.59 mg Fluocinolone Acetonide implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Inflammation Recurrence | Number of eyes with inflammation recurrence | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Improvement in Visual Acuity | Visual acuity was improved by two or more lines from baseline. | baseline to 52 weeks |
| Number of Participant's Eye Requiring Adjunctive Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn J Jaffe, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Eye Center | Durham | North Carolina | 27710 | United States |
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Of these 21 subjects, 14 subjects had recurrence of inflammation and were re-implanted
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.59 mg Fluocinolone Acetonide Implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of 21 consented subjects only 14 completed the 9 months follow-up in whom fluocinolone acetonide implants were replaced or who needed a second implant.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.59 mg Fluocinolone Acetonide Implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Eyes With Inflammation Recurrence | Number of eyes with inflammation recurrence | Posted | Number | eye with inflammation | 5 years | Number of eyes implanted | Participants |
|
|
5 years
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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 | 0.59 mg Fluocinolone Acetonide Implant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Infections and infestations | Systematic Assessment | Endophthalmitis is a known risk of ocular surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn J. Jaffe, MD | Duke University Medical Center | 919-684-4458 | jaffe001@mc.duke.edu |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Adjunctive Therapy needed to control inflammation in the implanted eye
| 5 years |
| Number of Eyes With Increased Intraocular Pressure | 52 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of eyes implanted |
|
|
| Secondary | Percentage of Eyes With Improvement in Visual Acuity | Visual acuity was improved by two or more lines from baseline. | There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy | Posted | Number | percentage of eyes improved | baseline to 52 weeks | Number of eyes implanted | Participants |
|
|
|
| Secondary | Number of Participant's Eye Requiring Adjunctive Therapy | Adjunctive Therapy needed to control inflammation in the implanted eye | There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy | Posted | Number | participant's eyes | 5 years | Number of eyes implanted | Participants |
|
|
|
| Secondary | Number of Eyes With Increased Intraocular Pressure | Posted | Number | eyes | 52 weeks | Number of eyes implanted | Participants |
|
|
|
| 0 |
| 14 |
| 2 |
| 14 |
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| Retinial Detachment | Eye disorders | Systematic Assessment | Retinal Detachment is a known risk of ocular surgery |
|
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| D012164 |
| Retinal Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Title | Measurements |
|---|---|
|
| Intravitreal triamcinolone acetonide injection |
|