Fluocinolone Acetonide Implant Compared to Sham Injection... | NCT00344968

Fluocinolone Acetonide Implant Compared to Sham Injection... | NCT00344968 | Trialant

Arms/Interventions Module

Label	Type	Intervention Names
1	Experimental	Drug: fluocinolone acetonide
2	Experimental	Drug: Fluocinolone Acetonide
3	Sham Comparator	Procedure: Standard of care laser photocoagulation

Name	Type	Description	Arm Group Labels	Other Names
fluocinolone acetonide	Drug	0.5 mg fluocinolone acetonide intravitreal insert	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Acuity	The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).	36 months

Secondary Outcomes

Measure	Description	Time Frame
Retinal Thickness	Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.	36 months

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33206392	Derived	Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
30569759	Derived	Holden SE, Kapik B, Beiderbeck AB, Currie CJ. Comparison of data characterizing the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world, non-interventional ICE-UK study and the FAME randomized controlled trials. Curr Med Res Opin. 2019 Jul;35(7):1165-1176. doi: 10.1080/03007995.2018.1560779. Epub 2019 Jan 17.

Arm/Group Information

ID	Title	Description
FG000	Sham Comparator	Procedure: Standard of care laser photocoagulation
FG001	Fluocinolone Acetonide: 0.2 ug/Day Implant	Dose 0.2 ug/day Medidur Implant
FG002	Fluocinolone Acetonide: 0.5 ug/Day Implant	Dose 0.5 ug/day Medidur implant

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000185 subjects FG001376 subjects FG002395 subjects
COMPLETED		FG000126 subjects FG001274 subjects FG002279 subjects
NOT COMPLETED		FG00059 subjects FG001102 subjects FG002116 subjects

Type	Comment	Reasons
Adverse Event		FG0005 subjects FG0014 subjects FG00215 subjects
Unsatisfactory Therapeutic Effect		FG000

Baseline Characteristics Module

ID	Title	Description
BG000	Sham Comparator	Procedure: Standard of care laser photocoagulation
BG001	0.2 ug/Day Implant	Dose 0.2 ug/day Medidur Implant

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical	Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.

Outcome Measures Module

Outcome Measures

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

Visual Acuity

The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).

Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.

Posted

Number

percentage of subjects

36 months

ID	Title	Description
OG000	Sham Comparator	Procedure: Standard of care laser photocoagulation
OG001	Fluocinolone Acetonide: 0.2 ug/Day Implant	Dose 0.2 ug/day Medidur implant

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sham Comparator	Standard of care laser photocoagulation

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Kathleen Billman, Senior Director of Scientific Affairs	Alimera Sciences, Inc.	678-572-1302		kathleen.billman@alimerasciences.com

Intervention Browse Module

ID	Term
D005446	Fluocinolone Acetonide

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Title

Denominators

Categories

<=18 years

Title	Measurements
	BG0000 BG0010 BG0020 BG0030

Between 18 and 65 years

Title	Measurements
	BG000119 BG001213 BG002232 BG003

>=65 years

Title	Measurements
	BG00066 BG001162 BG002161 BG003

Age, Continuous

Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.9± 9.6 BG00163.0± 9.3 BG00262.2± 9.3 BG00362.5± 9.4

Gender

Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00077 BG001160 BG002150 BG003387

Male

Title	Measurements
	BG000108 BG001215 BG002243 BG003

Region of Enrollment

Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.

Number

participants

Title

Denominators

Categories

North America

Title	Measurements
	BG000129 BG001259 BG002274 BG003662

India

Title	Measurements
	BG00039 BG00180 BG00282 BG003

Europe

Title	Measurements
	BG00017 BG00137 BG00239 BG003

Secondary

Retinal Thickness

Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.

Posted

Mean

Standard Deviation

microns

36 months

ID	Title	Description
OG000	Sham Comparator	Procedure: Standard of care laser photocoagulation
OG001	Fluocinolone Acetonide: 0.2 ug/Day Implant	Dose 0.2 ug/day Medidur Implant
OG002	Fluocinolone Acetonide: 0.5 ug/Day Implant	Dose 0.5 ug/day Medidur implant

Units	Counts
Participants	OG000182 OG001369 OG002388

Title

Denominators

Categories

Title	Measurements
	OG000146.1± 192.10 OG001113.5± 151.46 OG002131.8± 162.46