CompletedNCT00344968FAMEUpdated May 7, 2014Results posted

Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema

A Phase 3 interventional study of fluocinolone acetonide and Fluocinolone Acetonide in Diabetic Macular Edema, sponsored by Alimera Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-07.

Sponsored by Alimera Sciences · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 956
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.

Conditions studied

Diabetic Macular Edema

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In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 956 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Alimera Sciences is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age >= 18 years with diabetic macular edema
Diagnosis of diabetes mellitus types 1 or 2
Best corrected visual acuity of 19-68 letters
Retinal thickness > 250 micron by OCT
Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion criteria

Exclusion Criteria:

Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents
Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
Prior intravitreal, subtenon, or periocular steroid therapy within 6 months
Any ocular surgery within the last 3 months
Retinal laser treatment within the last 3 months
History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
Any lens opacity which impairs visualization of the posterior pole

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 956 participants (actual)

Study arms

Experimental
1
Drug: fluocinolone acetonide
Experimental
2
Drug: Fluocinolone Acetonide
Sham comparator
3
Procedure: Standard of care laser photocoagulation

Interventions

Drugfluocinolone acetonide
0.5 mg fluocinolone acetonide intravitreal insert
DrugFluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert
ProcedureStandard of care laser photocoagulation
Laser photocoagulation

What researchers measure

Primary outcomes

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).
Time frame: 36 months

Secondary outcomes

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.
Time frame: 36 months

Results

Posted May 7, 2014

Participant flow

Participant flow — Overall Study
Milestone	Sham Comparator	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Started	185	376	395
Completed	126	274	279
Not completed	59	102	116
Withdrew: Adverse event	5	4	15
Withdrew: Unsatisfactory therapeutic effect	3	0	1
Withdrew: Protocol violation	2	2	5
Withdrew: Withdrawal by subject	14	31	27
Withdrew: Lost to follow-up	24	37	37
Withdrew: Death	11	27	31
Withdrew: Other	0	1	0

Outcome measures

PrimaryVisual 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).

Time frame:: 36 months
Reported as:: Number · percentage of subjects

Visual Acuity
percentage of subjects	Sham Comparator	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Visual Acuity	18.9 ± 18.01	28.7 ± 19.04	27.8 ± 18.96

SecondaryRetinal 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.

Time frame:: 36 months
Reported as:: Mean · microns

Retinal Thickness
microns	Sham Comparator	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Retinal Thickness	146.1 ± 192.10	113.5 ± 151.46	131.8 ± 162.46

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sham Comparator	—	112/185 (60.5%)	174/185 (94.1%)
Fluocinolone Acetonide: 0.2 ug/Day Implant	—	292/375 (77.9%)	360/375 (96%)
Fluocinolone Acetonide: 0.5 ug/Day Implant	—	331/393 (84.2%)	388/393 (98.7%)

Most frequent serious events

Showing 10 of 415

Most frequent serious events
Event	Sham Comparator	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Cataract operationSurgical and medical procedures	33/185	188/375	231/393
Cataract operationSurgical and medical procedures	32/185	85/375	87/393
VitrectomySurgical and medical procedures	16/185	19/375	23/393
VitrectomySurgical and medical procedures	13/185	25/375	27/393
TrabeculectomySurgical and medical procedures	0/185	10/375	22/393
Intraocular pressure increasedInvestigations	0/185	12/375	20/393
Cardiac failure congestiveCardiac disorders	8/185	12/375	16/393
Vitreous haemorrhageEye disorders	8/185	5/375	9/393
Myocardial infarctionCardiac disorders	5/185	14/375	16/393
Coronary artery diseaseCardiac disorders	4/185	10/375	15/393

Most frequent other events

Showing 10 of 41

Most frequent other events
Event	Sham Comparator	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
CataractEye disorders	53/185	171/375	213/393
Intraocular pressure increasedInvestigations	21/185	129/375	169/393
CataractEye disorders	46/185	109/375	121/393
MyodesopsiaEye disorders	13/185	67/375	68/393
Eye painEye disorders	22/185	51/375	65/393
HypertensionVascular disorders	29/185	43/375	57/393
Vitreous haemorrhageEye disorders	25/185	38/375	46/393
Conjunctival haemorrhageEye disorders	20/185	43/375	50/393
Intraocular pressure increasedInvestigations	22/185	40/375	50/393
Vitreous haemorrhageEye disorders	22/185	36/375	49/393

Baseline characteristics

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.

Age, Categorical
Age, Categorical(participants)	Sham Comparator	0.2 ug/Day Implant	0.5 ug/Day Implant	Total
<=18 years	0	0	0	0
Between 18 and 65 years	119	213	232	564
>=65 years	66	162	161	389

Age, Continuous
Age, Continuous(years)	Sham Comparator	0.2 ug/Day Implant	0.5 ug/Day Implant	Total
Mean	61.9 ± 9.6	63.0 ± 9.3	62.2 ± 9.3	62.5 ± 9.4

Gender
Gender(participants)	Sham Comparator	0.2 ug/Day Implant	0.5 ug/Day Implant	Total
Female	77	160	150	387
Male	108	215	243	566

Region of Enrollment
Region of Enrollment(participants)	Sham Comparator	0.2 ug/Day Implant	0.5 ug/Day Implant	Total
North America	129	259	274	662
India	39	80	82	201
Europe	17	37	39	93

Study locations

1 site

Atlanta, Georgia, United States

References and documents

Publications

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. PubMed 33206392 ↗
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. PubMed 30569759 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00344968
Lead sponsor: Alimera Sciences
Responsible party: Sponsor
First posted: Jun 27, 2006
Start date: Sep 2007
Primary completion: Dec 2009
Completion: Dec 2010
Results posted: May 7, 2014
Last update: May 7, 2014

View the source record on ClinicalTrials.gov ↗

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