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Trial record 16 of 81 for:    CRVO - Central Retinal Vein Occlusion

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

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ClinicalTrials.gov Identifier: NCT00952614
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : June 30, 2014
Last Update Posted : August 6, 2014
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Glenn Jaffe, Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Central Retinal Vein Occlusion
Intervention Device: fluocinolone acetonide (Retisert Implant, Bausch and Lomb)
Enrollment 29
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Retisert for Retinal Vein Occlusion
Hide Arm/Group Description

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

Period Title: Overall Study
Started 30
Participants Started Treatment 30 [1]
Completed 23 [2]
Not Completed 7
Reason Not Completed
Death             3
Lost to Follow-up             3
other reason             1
[1]
29 subjects signed consent; 1 agreed for both eyes to enroll. 30 eyes rec'd drug delivery implant
[2]
3 subjects died from unrelated causes, 3 were lost to follow-up & 1 had both eyes included in study.
Arm/Group Title Retisert for Retinal Vein Occlusion
Hide Arm/Group Description

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 Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Twenty nine participants were consented. Of the 29 consented (30 eyes; one subject consented twice), 23 participants were studied and 24 eyes. Both eyes of one participant were studied
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
68  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
11
  36.7%
Male
19
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts
Hide Description Outcome measure based on eyes at time points with 10-letter ETDRS score improvement
Time Frame baseline (preoperatively) to 3 years postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retisert for Retinal Vein Occlusion
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 23
Mean (Full Range)
Unit of Measure: letters read correctly
Change in ETDRS @ 1 year after implant
12.5
(6 to 19)
Change in ETDRS @ 2 years after implant
14
(10 to 18)
Change in ETDRS @ 3 years after implant
13.5
(9 to 18)
2.Secondary Outcome
Title Improvement in Macular Edema on Optical Coherence Tomography and Color Photos
Hide Description 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.
Time Frame baseline (preoperatively) to 3 years postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retisert for Retinal Vein Occlusion
Hide Arm/Group Description:

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 Number of Participants Analyzed 23
Mean (Inter-Quartile Range)
Unit of Measure: improvement in TMV/mm^3
10.4
(9.0 to 11.7)
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Retisert for Retinal Vein Occlusion
Hide Arm/Group Description

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

All-Cause Mortality
Retisert for Retinal Vein Occlusion
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Retisert for Retinal Vein Occlusion
Affected / at Risk (%) # Events
Total   3/29 (10.34%)    
General disorders   
Death  [1]  3/23 (13.04%)  3
Indicates events were collected by systematic assessment
[1]
Unrelated to study activity. 29 subjects consented, 30 enrolled. 1 subject consented twice. Ocular AEs are based on 30 eyes.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Retisert for Retinal Vein Occlusion
Affected / at Risk (%) # Events
Total   1/29 (3.45%)    
Infections and infestations   
Endophthalmitis  [1]  1/29 (3.45%)  1
Indicates events were collected by systematic assessment
[1]
Developed 1 week after implant & resolved. Retinal Detachment (RD) developed months later; implant was removed during RD repair. 29 subjects consented, 30 enrolled. 1 subject consented twice. Ocular AEs are based on 30 eyes
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Glenn J. Jaffe, MD
Organization: Duke University Medical Center
Phone: 919-684-4458
Responsible Party: Glenn Jaffe, Duke University
ClinicalTrials.gov Identifier: NCT00952614     History of Changes
Other Study ID Numbers: Pro00007284
7300 ( Other Identifier: Duke legacy protocol ID )
First Submitted: August 4, 2009
First Posted: August 6, 2009
Results First Submitted: August 6, 2013
Results First Posted: June 30, 2014
Last Update Posted: August 6, 2014