Diabetic Macular Edema (DME)
Conditions
Brief summary
This observational study aims to assess the safety and effect of Iluvien® in DME patients considered insufficiently responsive to available therapies in a real life setting in Germany.
Interventions
None listed
Sponsors
Alimera Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients of both sexes that have signed informed consent after detailed information about the characteristics of the observation by the physician * DME based on physician's clinical evaluation and demonstrated on fundus photographs and/or optical coherence tomography (OCT); * Vision impairment associated with DME * Prior treatment with available therapies for DME; and * Patients considered by the physician insufficiently responsive to available therapies
Exclusion criteria
* Patients with contraindications according to the current Summary of Product Characteristics (SPC) * The presence of pre-existing glaucoma * Active or suspected ocular or periocular infection * The patient is hypersensitive to the active agent or to one of the excipients * Elevated IOP * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Ocular Adverse Events | 24 Months | — |
| Visual Acuity | 24 Months | Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal Center Subfield Thickness | 24 months | Observed and change from baseline SD-OCT values will be summarized using descriptive statistics. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic DME Patients with vision impairment associated with chronic diabetic macular edema (DME) | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Other | 1 |
| Overall Study | Study Terminated | 22 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Chronic DME |
|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 9.02 |
| Region of Enrollment Germany | 23 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 23 |
| serious Total, serious adverse events | 4 / 23 |
Outcome results
Primary
Number of Patients With Ocular Adverse Events
Time frame: 24 Months
Population: 23 Patients received ILUVIEN, one patient was treated bilaterally
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chronic DME | Number of Patients With Ocular Adverse Events | 7 participants |
Primary
Visual Acuity
Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.
Time frame: 24 Months
Population: 23 Patients received ILUVIEN, one patient was treated bilaterally
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic DME | Visual Acuity | -0.025 LogMAR | Standard Error 0.0357 |
Secondary
Retinal Center Subfield Thickness
Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.
Time frame: 24 months
Population: 23 Patients received ILUVIEN, one patient was treated bilaterally
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic DME | Retinal Center Subfield Thickness | 357.0 microns | Standard Deviation 136.44 |