Diabetic Macular Edema
Conditions
Brief summary
This study will evaluate the 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
0.2 mg fluocinolone acetonide intravitreal insert
Laser photocoagulation
Sponsors
Alimera Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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 19-68 letters * Retinal thickness \> 250 micron 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 6 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 |
|---|---|---|
| Visual Acuity | 36 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal Thickness | 36 months | Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham Comparator Procedure: Standard of care laser photocoagulation | 185 |
| 0.2 ug/Day Implant Dose 0.2 ug/day Medidur Implant | 376 |
| 0.5 ug/Day Implant Dose 0.5 ug/day Medidur implant | 395 |
| Total | 956 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 | 15 |
| Overall Study | Death | 11 | 27 | 31 |
| Overall Study | Lost to Follow-up | 24 | 37 | 37 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 2 | 5 |
| Overall Study | Unsatisfactory Therapeutic Effect | 3 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 14 | 31 | 27 |
Baseline characteristics
| Characteristic | 0.2 ug/Day Implant | 0.5 ug/Day Implant | Sham Comparator | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 162 participants | 161 participants | 66 participants | 389 participants |
| Age, Categorical Between 18 and 65 years | 213 participants | 232 participants | 119 participants | 564 participants |
| Age, Continuous | 63.0 years STANDARD_DEVIATION 9.3 | 62.2 years STANDARD_DEVIATION 9.3 | 61.9 years STANDARD_DEVIATION 9.6 | 62.5 years STANDARD_DEVIATION 9.4 |
| Gender Female | 160 participants | 150 participants | 77 participants | 387 participants |
| Gender Male | 215 participants | 243 participants | 108 participants | 566 participants |
| Region of Enrollment Europe | 37 participants | 39 participants | 17 participants | 93 participants |
| Region of Enrollment India | 80 participants | 82 participants | 39 participants | 201 participants |
| Region of Enrollment North America | 259 participants | 274 participants | 129 participants | 662 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 174 / 185 | 360 / 375 | 388 / 393 |
| serious Total, serious adverse events | 112 / 185 | 292 / 375 | 331 / 393 |
Outcome results
Primary
Visual Acuity
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).
Time frame: 36 months
Population: Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Sham Comparator | Visual Acuity | 18.9 percentage of subjects | 18.01 |
| Fluocinolone Acetonide: 0.2 ug/Day Implant | Visual Acuity | 28.7 percentage of subjects | 19.04 |
| Fluocinolone Acetonide: 0.5 ug/Day Implant | Visual Acuity | 27.8 percentage of subjects | 18.96 |
Secondary
Retinal Thickness
Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.
Time frame: 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Comparator | Retinal Thickness | 146.1 microns | Standard Deviation 192.1 |
| Fluocinolone Acetonide: 0.2 ug/Day Implant | Retinal Thickness | 113.5 microns | Standard Deviation 151.46 |
| Fluocinolone Acetonide: 0.5 ug/Day Implant | Retinal Thickness | 131.8 microns | Standard Deviation 162.46 |