Trial · NCT00490815
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
NCT00490815, Phase 3, Completed, Alimera Sciences; results first posted 2014-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema. Trials, record NCT00490815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00490815
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
- NCT number
- NCT00490815
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 37 participants, actual
- Lead sponsor
- Alimera Sciences
- Conditions
- Diabetic Macular Edema
- Interventions
- Fluocinolone Acetonide, Fluocinolone Acetonide
- First posted
- 2007-06-25
- Last updated
- 2014-02-13
- Results first posted
- 2014-02-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor | over 36 months | This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data. |
| Secondary | Retinal Thickness | over 36 months |
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 | Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor | over 36 months | pg/ml | MEAN | |
| SECONDARY | Retinal Thickness | over 36 months | µg | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor | Fluocinolone Acetonide: 0.2 ug/Day Implant | 1.4905 | Standard Deviation 1.87058 | pg/ml | |
| Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor | Fluocinolone Acetonide: 0.5 ug/Day Implant | 0.7140 | Standard Deviation 0.78096 | pg/ml | |
| Retinal Thickness | Fluocinolone Acetonide: 0.2 ug/Day Implant | 343.8 | Standard Deviation 142.92 | µg | |
| Retinal Thickness | Fluocinolone Acetonide: 0.5 ug/Day Implant | 324.2 | Standard Deviation 136.86 | µg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluocinolone Acetonide: 0.2 ug/Day Implant | 20 | |
| Overall Study | STARTED | Fluocinolone Acetonide: 0.5 ug/Day Implant | 17 | |
| Overall Study | COMPLETED | Fluocinolone Acetonide: 0.2 ug/Day Implant | 12 | |
| Overall Study | COMPLETED | Fluocinolone Acetonide: 0.5 ug/Day Implant | 8 | |
| Overall Study | NOT COMPLETED | Fluocinolone Acetonide: 0.2 ug/Day Implant | 8 | |
| Overall Study | NOT COMPLETED | Fluocinolone Acetonide: 0.5 ug/Day Implant | 9 |
Source ClinicalTrials.gov
Adverse events454
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: 0.2 ug/Day Implant | 1 | 20 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Fluocinolone Acetonide: 0.5 ug/Day Implant | 1 | 17 | 1 |
| other | Coagulopathy | Blood and lymphatic system disorders | Fluocinolone Acetonide: 0.2 ug/Day Implant | 0 | 20 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Fluocinolone Acetonide: 0.5 ug/Day Implant | 1 | 17 | 1 |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Fluocinolone Acetonide: 0.2 ug/Day Implant | 1 | 20 | 1 |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Fluocinolone Acetonide: 0.5 ug/Day Implant | 0 | 17 | 0 |
| other | Aortic valve stenosis | Cardiac disorders | Fluocinolone Acetonide: 0.2 ug/Day Implant | 1 | 20 | 1 |
| other | Aortic valve stenosis | Cardiac disorders | Fluocinolone Acetonide: 0.5 ug/Day Implant | 0 | 17 | 0 |
| other | Arrhythmia | Cardiac disorders | Fluocinolone Acetonide: 0.2 ug/Day Implant | 1 | 20 | 1 |
| other | Arrhythmia | Cardiac disorders | Fluocinolone Acetonide: 0.5 ug/Day Implant | 1 | 17 | 1 |
1 to 10 of 454Source ClinicalTrials.gov
See all 454 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| 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 | Fluocinolone Acetonide: 0.2 ug/Day Implant | 20 | 20 |
| Total, other adverse events | Fluocinolone Acetonide: 0.5 ug/Day Implant | 15 | 17 |
| Total, serious adverse events | Fluocinolone Acetonide: 0.2 ug/Day Implant | 19 | 20 |
| Total, serious adverse events | Fluocinolone Acetonide: 0.5 ug/Day Implant | 12 | 17 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fluocinolone Acetonide: 0.2 ug/Day Implant vs Fluocinolone Acetonide: 0.5 ug/Day Implant: serious adverse events |
Source Trial comparisons
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/NCT00490815
GET https://conductscience.org/api/trials/v1/NCT00490815/events?page=2