Trial Outcomes & Findings for Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment (NCT NCT00543296)

Results Overview

Number of eyes with inflammation recurrence

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

5 years

Results posted on

2015-03-31

Participant Flow

Of these 21 subjects, 14 subjects had recurrence of inflammation and were re-implanted

Participant milestones

Participant milestones
Measure	0.59 mg Fluocinolone Acetonide Implant
Overall Study STARTED	21
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	0.59 mg Fluocinolone Acetonide Implant
Overall Study Physician Decision	7

Baseline Characteristics

Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.59 mg Fluocinolone Acetonide Implant n=14 Participants
Age, Continuous	50.0 years STANDARD_DEVIATION 12.9 • n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Region of Enrollment United States	14 participants n=99 Participants

PRIMARY outcome

Timeframe: 5 years

Number of eyes with inflammation recurrence

Outcome measures

Outcome measures
Measure	0.59 mg Fluocinolone Acetonide Implant n=17 Number of eyes implanted
Number of Eyes With Inflammation Recurrence	1 eye with inflammation

SECONDARY outcome

Timeframe: 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

Visual acuity was improved by two or more lines from baseline.

Outcome measures

Outcome measures
Measure	0.59 mg Fluocinolone Acetonide Implant n=17 Number of eyes implanted
Percentage of Eyes With Improvement in Visual Acuity	45 percentage of eyes improved

SECONDARY outcome

Timeframe: 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

Adjunctive Therapy needed to control inflammation in the implanted eye

Outcome measures

Outcome measures
Measure	0.59 mg Fluocinolone Acetonide Implant n=17 Number of eyes implanted
Number of Participant's Eye Requiring Adjunctive Therapy Topical corticosteroids	12 participant's eyes
Number of Participant's Eye Requiring Adjunctive Therapy SubTenon triamcinolone acetonide injection	7 participant's eyes
Number of Participant's Eye Requiring Adjunctive Therapy Prednisone	1 participant's eyes
Number of Participant's Eye Requiring Adjunctive Therapy Intravitreal triamcinolone acetonide injection	4 participant's eyes

SECONDARY outcome

Timeframe: 52 weeks

Outcome measures

Outcome measures
Measure	0.59 mg Fluocinolone Acetonide Implant n=17 Number of eyes implanted
Number of Eyes With Increased Intraocular Pressure	2 eyes

Adverse Events

0.59 mg Fluocinolone Acetonide Implant

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0.59 mg Fluocinolone Acetonide Implant n=14 participants at risk
Infections and infestations Endophthalmitis	7.1% 1/14 • Number of events 1 • 5 years
Eye disorders Retinial Detachment	7.1% 1/14 • Number of events 1 • 5 years

Additional Information

Glenn J. Jaffe, MD

Duke University Medical Center

Phone: 919-684-4458

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place