Uveitis
Conditions
Keywords
uveitis, Cystoid Macular Edema (CME), fluocinolone acetonide, non-infectious uveitis affecting the posterior segment
Brief summary
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.
Detailed description
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
Interventions
DRUG0.59 mg Fluocinolone Acetonide implant
0.59 mg Fluocinolone Acetonide implant
Sponsors
Bausch & Lomb Incorporated
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Non-infectious intermediate, posterior or panuveitis * Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug
Exclusion criteria
* Infectious uveitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Inflammation Recurrence | 5 years | Number of eyes with inflammation recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Improvement in Visual Acuity | baseline to 52 weeks | Visual acuity was improved by two or more lines from baseline. |
| Number of Participant's Eye Requiring Adjunctive Therapy | 5 years | Adjunctive Therapy needed to control inflammation in the implanted eye |
| Number of Eyes With Increased Intraocular Pressure | 52 weeks | — |
Countries
United States
Participant flow
Recruitment details
Of these 21 subjects, 14 subjects had recurrence of inflammation and were re-implanted
Participants by arm
| Arm | Count |
|---|---|
| 0.59 mg Fluocinolone Acetonide Implant | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 7 |
Baseline characteristics
| Characteristic | 0.59 mg Fluocinolone Acetonide Implant |
|---|---|
| Age, Continuous | 50.0 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Number of Eyes With Inflammation Recurrence
Number of eyes with inflammation recurrence
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.59 mg Fluocinolone Acetonide Implant | Number of Eyes With Inflammation Recurrence | 1 eye with inflammation |
Secondary
Number of Eyes With Increased Intraocular Pressure
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.59 mg Fluocinolone Acetonide Implant | Number of Eyes With Increased Intraocular Pressure | 2 eyes |
Secondary
Number of Participant's Eye Requiring Adjunctive Therapy
Adjunctive Therapy needed to control inflammation in the implanted eye
Time frame: 5 years
Population: There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.59 mg Fluocinolone Acetonide Implant | Number of Participant's Eye Requiring Adjunctive Therapy | Topical corticosteroids | 12 participant's eyes |
| 0.59 mg Fluocinolone Acetonide Implant | Number of Participant's Eye Requiring Adjunctive Therapy | SubTenon triamcinolone acetonide injection | 7 participant's eyes |
| 0.59 mg Fluocinolone Acetonide Implant | Number of Participant's Eye Requiring Adjunctive Therapy | Prednisone | 1 participant's eyes |
| 0.59 mg Fluocinolone Acetonide Implant | Number of Participant's Eye Requiring Adjunctive Therapy | Intravitreal triamcinolone acetonide injection | 4 participant's eyes |
Secondary
Percentage of Eyes With Improvement in Visual Acuity
Visual acuity was improved by two or more lines from baseline.
Time frame: baseline to 52 weeks
Population: There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.59 mg Fluocinolone Acetonide Implant | Percentage of Eyes With Improvement in Visual Acuity | 45 percentage of eyes improved |