Trial · NCT00344968

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

NCT00344968, Phase 3, Completed, Alimera Sciences; results first posted 2014-05-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema. Trials, record NCT00344968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00344968

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
NCT number: NCT00344968
Status: Completed
Phases: Phase 3
Enrollment: 956 participants, actual
Lead sponsor: Alimera Sciences
Conditions: Diabetic Macular Edema
Interventions: fluocinolone acetonide, Fluocinolone Acetonide, Standard of care laser photocoagulation
First posted: 2006-06-27
Last updated: 2014-05-07
Results first posted: 2014-05-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Visual Acuity	36 months	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).
Secondary	Retinal Thickness	36 months	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Visual Acuity	36 months	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.	percentage of subjects	NUMBER
SECONDARY	Retinal Thickness	36 months		microns	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Visual Acuity	Sham Comparator	18.9	18.01	percentage of subjects
Visual Acuity	Fluocinolone Acetonide: 0.2 ug/Day Implant	28.7	19.04	percentage of subjects
Visual Acuity	Fluocinolone Acetonide: 0.5 ug/Day Implant	27.8	18.96	percentage of subjects
Retinal Thickness	Sham Comparator	146.1	Standard Deviation 192.10	microns
Retinal Thickness	Fluocinolone Acetonide: 0.2 ug/Day Implant	113.5	Standard Deviation 151.46	microns
Retinal Thickness	Fluocinolone Acetonide: 0.5 ug/Day Implant	131.8	Standard Deviation 162.46	microns

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sham Comparator	185
Overall Study	STARTED	Fluocinolone Acetonide: 0.2 ug/Day Implant	376
Overall Study	STARTED	Fluocinolone Acetonide: 0.5 ug/Day Implant	395
Overall Study	COMPLETED	Sham Comparator	126
Overall Study	COMPLETED	Fluocinolone Acetonide: 0.2 ug/Day Implant	274
Overall Study	COMPLETED	Fluocinolone Acetonide: 0.5 ug/Day Implant	279
Overall Study	NOT COMPLETED	Sham Comparator	59
Overall Study	NOT COMPLETED	Fluocinolone Acetonide: 0.2 ug/Day Implant	102
Overall Study	NOT COMPLETED	Fluocinolone Acetonide: 0.5 ug/Day Implant	116

Source ClinicalTrials.gov

Adverse events1,368

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Sham Comparator	9	185	9
other	Anaemia	Blood and lymphatic system disorders	Fluocinolone Acetonide: 0.2 ug/Day Implant	33	375	36
other	Anaemia	Blood and lymphatic system disorders	Fluocinolone Acetonide: 0.5 ug/Day Implant	42	393	46
other	Cataract	Eye disorders	Sham Comparator	53	185	54
other	Cataract	Eye disorders	Fluocinolone Acetonide: 0.2 ug/Day Implant	171	375	183
other	Cataract	Eye disorders	Fluocinolone Acetonide: 0.5 ug/Day Implant	213	393	234
other	Cataract	Eye disorders	Sham Comparator	46	185	47
other	Cataract	Eye disorders	Fluocinolone Acetonide: 0.2 ug/Day Implant	109	375	115
other	Cataract	Eye disorders	Fluocinolone Acetonide: 0.5 ug/Day Implant	121	393	127
other	Cataract subcapsular	Eye disorders	Sham Comparator	8	185	9

1 to 10 of 1,368Source ClinicalTrials.gov

See all 1,368 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sham Comparator
Total, all-cause mortality	Fluocinolone Acetonide: 0.2 ug/Day Implant
Total, all-cause mortality	Fluocinolone Acetonide: 0.5 ug/Day Implant
Total, other adverse events	Sham Comparator	174	185
Total, other adverse events	Fluocinolone Acetonide: 0.2 ug/Day Implant	360	375
Total, other adverse events	Fluocinolone Acetonide: 0.5 ug/Day Implant	388	393
Total, serious adverse events	Sham Comparator	112	185
Total, serious adverse events	Fluocinolone Acetonide: 0.2 ug/Day Implant	292	375
Total, serious adverse events	Fluocinolone Acetonide: 0.5 ug/Day Implant	331	393

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30569759	DERIVED	PubMed
33206392	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00344968

GET https://conductscience.org/api/trials/v1/NCT00344968/events?page=2

API reference For AI assistants