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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic DME | Patients with vision impairment associated with chronic diabetic macular edema (DME) |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics. | 24 Months |
| Number of Patients With Ocular Adverse Events | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Center Subfield Thickness | Observed and change from baseline SD-OCT values will be summarized using descriptive statistics. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with DME considered insufficiently responsive to available therapies in approximately 25 ophthalmology centers (private practice or hospital) across Germany
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| Name | Affiliation | Role |
|---|---|---|
| Professor Helmut Hoeh, MD | Dietrich-Bonhoeffer-Klinikum | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neubrandenburg | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic DME | Patients with vision impairment associated with chronic diabetic macular edema (DME) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
25 patients were enrolled but only 23 received treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic DME | Patients with vision impairment associated with chronic diabetic macular edema (DME) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity | Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics. | 23 Patients received ILUVIEN, one patient was treated bilaterally | Posted | Mean | Standard Error | LogMAR | 24 Months | Eyes | Participants |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic DME | Patients with vision impairment associated with chronic diabetic macular edema (DME) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cerebral hemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cataract op on contralateral eye | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Joyson - Associate Director, Clinical Operations Europe | Alimera Sciences, Ltd. | +44 1252 354 026 | Andrew.Joyson@alimerasciences.com |
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| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eyes |
|
|
| Primary | Number of Patients With Ocular Adverse Events | 23 Patients received ILUVIEN, one patient was treated bilaterally | Posted | Number | participants | 24 Months | Eyes | Participants |
|
|
|
| Secondary | Retinal Center Subfield Thickness | Observed and change from baseline SD-OCT values will be summarized using descriptive statistics. | 23 Patients received ILUVIEN, one patient was treated bilaterally | Posted | Mean | Standard Deviation | microns | 24 months | Eyes | Participants |
|
|
|
| 4 |
| 23 |
| 8 |
| 23 |
| phacoemulsification of left eye | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
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| suspected slight apoplex | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| increase of IOP | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| temporal periphere avascular areals | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| significant worsening of macular edema | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| hemorrhage of vitreous | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| planned implantation of catheter into atrium | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| implantation of shunt into left arm | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
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| excision of atrium catheter | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
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| eczema in face and on elbows | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| hyposphagma | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| conjunctival injection, moderate inflammation in anterior chamber | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| posterior capsular fibrosis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| epiretinal gliosis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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