Trial · NCT01304706
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
NCT01304706, Phase 3, Completed, Alimera Sciences; results first posted 2015-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study. Trials, record NCT01304706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01304706
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
- NCT number
- NCT01304706
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- Alimera Sciences
- Conditions
- Diabetic Macular Edema
- Interventions
- Fluocinolone Acetonide
- First posted
- 2011-02-25
- Last updated
- 2015-05-04
- Results first posted
- 2015-05-04
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 12 months | This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | 12 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Fluocinolone Acetonide | Adverse Event | 100 | participants | |
| Number of Participants With Adverse Events | Fluocinolone Acetonide | Serious Adverse Event | 42 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluocinolone Acetonide | 121 | |
| Overall Study | COMPLETED | Fluocinolone Acetonide | 104 | |
| Overall Study | NOT COMPLETED | Fluocinolone Acetonide | 17 |
Source ClinicalTrials.gov
Adverse events281
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 | Fluocinolone Acetonide | 6 | 120 | 6 |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Fluocinolone Acetonide | 1 | 120 | 1 |
| other | Angina unstable | Cardiac disorders | Fluocinolone Acetonide | 1 | 120 | 1 |
| other | Aortic valve sclerosis | Cardiac disorders | Fluocinolone Acetonide | 1 | 120 | 1 |
| other | Arrhythmia | Cardiac disorders | Fluocinolone Acetonide | 1 | 120 | 1 |
| other | Arteriosclerosis coronary artery | Cardiac disorders | Fluocinolone Acetonide | 1 | 120 | 1 |
| other | Cardiac failure congestive | Cardiac disorders | Fluocinolone Acetonide | 1 | 120 | 1 |
| other | Cardiomegaly | Cardiac disorders | Fluocinolone Acetonide | 2 | 120 | 2 |
| other | Coronary artery disease | Cardiac disorders | Fluocinolone Acetonide | 1 | 120 | 1 |
| other | Pericardial effusion | Cardiac disorders | Fluocinolone Acetonide | 1 | 120 | 1 |
1 to 10 of 281Source ClinicalTrials.gov
See all 281 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluocinolone Acetonide | ||
| Total, other adverse events | Fluocinolone Acetonide | 100 | 120 |
| Total, serious adverse events | Fluocinolone Acetonide | 42 | 120 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT01304706
GET https://conductscience.org/api/trials/v1/NCT01304706/events?page=2