Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01304706 | Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study | PHASE3 | COMPLETED | 120 | — | — | Apr 1, 2011 | - | May 4, 2015 | 1 | United States |
| NCT00344968 | Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema | PHASE3 | COMPLETED | 956 | — | — | Sep 1, 2007 | Dec 1, 2010 | May 7, 2014 | 1 | United States |
| NCT00490815 | Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema | PHASE3 | COMPLETED | 37 | — | — | Aug 1, 2007 | Apr 1, 2011 | Feb 13, 2014 | 1 | United States |
This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.
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).
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.
| Arm | Type | Description |
|---|---|---|
| Fluocinolone Acetonide | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fluocinolone Acetonide | DRUG | 0.2 μg/day |
| Standard of care laser photocoagulation | PROCEDURE | Laser photocoagulation |
Inclusion Criteria: 1. Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies. 2. In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN. 3. Ability and willingness to comp...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | — | ADVM-022 |