Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies
Terminated
- Conditions
- Diabetic Macular Edema (DME)
- Registration Number
- NCT02080091
- Lead Sponsor
- Alimera Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Retinal Center Subfield Thickness 24 months Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.