An observational study in Diabetic Macular Edema (DME), sponsored by Alimera Sciences. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-26.
Sponsored by Alimera Sciences · Observational
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 25 is below the median of 97 across 163 observational studies indexed under Macular Edema.
Browse Macular Edema studies →Alimera Sciences is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with DME considered insufficiently responsive to available therapies in approximately 25 ophthalmology centers (private practice or hospital) across Germany
Exclusion Criteria:
Patients with vision impairment associated with chronic diabetic macular edema (DME)
Visual Acuity
Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.
Time frame: 24 Months
Number of Patients With Ocular Adverse Events
Time frame: 24 Months
Retinal Center Subfield Thickness
Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.
Time frame: 24 months
| Milestone | Chronic DME |
|---|---|
| Started | 25 |
| Completed | 0 |
| Not completed | 25 |
| Withdrew: Study terminated | 22 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Other | 1 |
Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.
| LogMAR | Chronic DME |
|---|---|
| Visual Acuity | -0.025 ± 0.0357 |
| participants | Chronic DME |
|---|---|
| Number of Patients With Ocular Adverse Events | 7 |
Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.
| microns | Chronic DME |
|---|---|
| Retinal Center Subfield Thickness | 357.0 ± 136.44 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chronic DME | — | 4/23 (17.4%) | 8/23 (34.8%) |
| Event | Chronic DME |
|---|---|
| cerebral hemorrhageNervous system disorders | 2/23 |
| strokeNervous system disorders | 2/23 |
| phacoemulsification of left eyeSurgical and medical procedures | 1/23 |
| suspected slight apoplexNervous system disorders | 1/23 |
| Event | Chronic DME |
|---|---|
| hyposphagmaEye disorders | 2/23 |
| cataract op on contralateral eyeSurgical and medical procedures | 1/23 |
| increase of IOPInvestigations | 1/23 |
| temporal periphere avascular arealsEye disorders | 1/23 |
| significant worsening of macular edemaEye disorders | 1/23 |
| hemorrhage of vitreousEye disorders | 1/23 |
| planned implantation of catheter into atriumInvestigations | 1/23 |
| implantation of shunt into left armSurgical and medical procedures | 1/23 |
| excision of atrium catheterSurgical and medical procedures | 1/23 |
| eczema in face and on elbowsSkin and subcutaneous tissue disorders | 1/23 |
25 patients were enrolled but only 23 received treatment.
| Age, Continuous(years) | Chronic DME |
|---|---|
| Mean | 67.4 ± 9.02 |
| Sex: Female, Male(Participants) | Chronic DME |
|---|---|
| Female | 11 |
| Male | 12 |
| Region of Enrollment(participants) | Chronic DME |
|---|---|
| Germany | 23 |
This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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