Diabetic Macular Edema
Conditions
Brief summary
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
Interventions
0.5 mg fluocinolone acetonide intravitreal insert
Sponsors
Alimera Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years with diabetic macular edema * Diagnosis of diabetes mellitus types 1 or 2 * Best corrected visual acuity of ≥ 19 letters * Retinal thickness \> 250 microns by OCT * Investigator is comfortable deferring macular laser treatment for 6 weeks
Exclusion criteria
* Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents * Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy * Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months * Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months * Any ocular surgery within the last 3 months * Retinal laser treatment within the last 3 months * History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy * Any lens opacity which impairs visualization of the posterior pole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Retinal Thickness | over 36 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluocinolone Acetonide: 0.2 ug/Day Implant Dose 0.2 ug/day Medidur Implant | 20 |
| Fluocinolone Acetonide: 0.5 ug/Day Implant Dose 0.5 ug/day Medidur Implant | 17 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Death | 1 | 3 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Fluocinolone Acetonide: 0.5 ug/Day Implant | Fluocinolone Acetonide: 0.2 ug/Day Implant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Continuous | 67.4 years STANDARD_DEVIATION 10.3 | 66.6 years STANDARD_DEVIATION 9.4 | 66.9 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 17 participants | 20 participants | 37 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 20 | 15 / 17 |
| serious Total, serious adverse events | 19 / 20 | 12 / 17 |
Outcome results
Primary
Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor
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.
Time frame: over 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluocinolone Acetonide: 0.2 ug/Day Implant | Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor | 1.4905 pg/ml | Standard Deviation 1.87058 |
| Fluocinolone Acetonide: 0.5 ug/Day Implant | Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor | 0.7140 pg/ml | Standard Deviation 0.78096 |
Secondary
Retinal Thickness
Time frame: over 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluocinolone Acetonide: 0.2 ug/Day Implant | Retinal Thickness | 343.8 µg | Standard Deviation 142.92 |
| Fluocinolone Acetonide: 0.5 ug/Day Implant | Retinal Thickness | 324.2 µg | Standard Deviation 136.86 |