Trial · NCT01694186
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
NCT01694186, Phase 3, Completed, EyePoint Pharmaceuticals, Inc.; results first posted 2020-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert. Trials, record NCT01694186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01694186
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
- NCT number
- NCT01694186
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 129 participants, actual
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Conditions
- Non-Infectious Uveitis
- Interventions
- FAI insert, Sham injection
- First posted
- 2012-09-27
- Last updated
- 2021-04-02
- Results first posted
- 2020-03-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | 36 months | Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment. |
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 | Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | 36 months | Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months (ITT Population)~Overall Summary of Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (Safety Population) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | Sham Injection | Protocol-Defined Recurrence of Uveitis | 12 | Participants | |
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | FAI Insert | Protocol-Defined Recurrence of Uveitis | 5 | Participants | |
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | Sham Injection | Ocular TEAE | 39 | Participants | |
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | FAI Insert | Ocular TEAE | 77 | Participants | |
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | Sham Injection | Ocular Serious TEAE | 12 | Participants | |
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | FAI Insert | Ocular Serious TEAE | 16 | Participants | |
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | Sham Injection | Ocular Treatment- Related TEAE | 21 | Participants | |
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | FAI Insert | Ocular Treatment- Related TEAE | 60 | Participants | |
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | Sham Injection | Ocular Treatment-Related Serious TEAE | 2 | Participants | |
| Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit | FAI Insert | Ocular Treatment-Related Serious TEAE | 11 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sham Injection | 42 | |
| Overall Study | STARTED | FAI Insert | 87 | |
| Overall Study | COMPLETED | Sham Injection | 36 | |
| Overall Study | COMPLETED | FAI Insert | 80 | |
| Overall Study | NOT COMPLETED | Sham Injection | 6 | |
| Overall Study | NOT COMPLETED | FAI Insert | 7 |
Source ClinicalTrials.gov
Adverse events142
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 | Hypertension | Vascular disorders | Sham Injection | 4 | 42 | 4 |
| other | Hypertension | Vascular disorders | FAI Insert | 6 | 87 | 6 |
| other | Intraocular pressure increased | Investigations | Sham Injection | 13 | 42 | 13 |
| other | Intraocular pressure increased | Investigations | FAI Insert | 28 | 87 | 28 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Sham Injection | 4 | 42 | 4 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | FAI Insert | 1 | 87 | 1 |
| other | Headache | Nervous system disorders | Sham Injection | 3 | 42 | 3 |
| other | Headache | Nervous system disorders | FAI Insert | 6 | 87 | 6 |
| other | Anterior chamber flare | Eye disorders | Sham Injection | 3 | 42 | 3 |
| other | Anterior chamber flare | Eye disorders | FAI Insert | 0 | 87 | 0 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sham Injection | 0 | 42 |
| Total, all-cause mortality | FAI Insert | 1 | 87 |
| Total, other adverse events | Sham Injection | 40 | 42 |
| Total, other adverse events | FAI Insert | 84 | 87 |
| Total, serious adverse events | Sham Injection | 17 | 42 |
| Total, serious adverse events | FAI Insert | 29 | 87 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32624244 | DERIVED |
Source 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FAI Insert vs Sham Injection: deaths from any cause | Trial comparisons |
| FAI Insert vs Sham Injection: serious adverse events | 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/NCT01694186
GET https://conductscience.org/api/trials/v1/NCT01694186/events?page=2