Trial Outcomes & Findings for A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion (NCT NCT00952614)

NCT ID: NCT00952614

Last Updated: 2014-08-06

Results Overview

Outcome measure based on eyes at time points with 10-letter ETDRS score improvement

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: baseline (preoperatively) to 3 years postoperatively
• Results posted on: 2014-08-06

Participant Flow

Twenty nine (29) participants were consented, 30 eyes. Of the 29 consented, there were 23 subjects included in the data pool of which one subject had both eyes included in the study.

Participant milestones

Measure	Retisert for Retinal Vein Occlusion 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide
Overall Study STARTED	30
Overall Study Participants Started Treatment	30
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Retisert for Retinal Vein Occlusion 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide
Overall Study Death	3
Overall Study Lost to Follow-up	3
Overall Study other reason	1

Baseline Characteristics

A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion

Baseline characteristics by cohort

Measure	Retisert for Retinal Vein Occlusion n=30 Participants 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide
Age, Continuous	68 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline (preoperatively) to 3 years postoperatively

Outcome measure based on eyes at time points with 10-letter ETDRS score improvement

Outcome measures

Measure	Retisert for Retinal Vein Occlusion n=23 Participants 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide Measure visual acuity improvement from baseline to time periods of 1,2, and 3 years.
Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts Change in ETDRS @ 1 year after implant	12.5 letters read correctly Interval 6.0 to 19.0
Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts Change in ETDRS @ 2 years after implant	14 letters read correctly Interval 10.0 to 18.0
Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts Change in ETDRS @ 3 years after implant	13.5 letters read correctly Interval 9.0 to 18.0

SECONDARY outcome

Timeframe: baseline (preoperatively) to 3 years postoperatively

Anatomic Change in reading of the size of the area of retinal thickening on color photographs and OCT. Total Macular Volume (TMV) in mm^3, is the calculated volume from the layers of the retina based off OCT imaging.

Outcome measures

Measure	Retisert for Retinal Vein Occlusion n=23 Participants 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide Measure visual acuity improvement from baseline to time periods of 1,2, and 3 years.
Improvement in Macular Edema on Optical Coherence Tomography and Color Photos	10.4 improvement in TMV/mm^3 Interval 9.0 to 11.7

Adverse Events

Retisert for Retinal Vein Occlusion

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Retisert for Retinal Vein Occlusion n=29 participants at risk 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide
General disorders Death	13.0% 3/23 • Number of events 3 • 3 years

Other adverse events

Measure	Retisert for Retinal Vein Occlusion n=29 participants at risk 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide
Infections and infestations Endophthalmitis	3.4% 1/29 • Number of events 1 • 3 years

Additional Information

Glenn J. Jaffe, MD

Duke University Medical Center

Phone: 919-684-4458

Email: jaffe001@mc.duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place