Status:
COMPLETED
Aflibercept in Patients With Pigment Epithelial Detachments (PED)
Lead Sponsor:
University Hospital Muenster
Conditions:
Pigment Epithelial Detachment
Eligibility:
All Genders
50+ years
Brief Summary
Uncontrolled single site non randomized non interventional study to determine the safety and efficacy of intravitreal injections of Aflibercept in patients with recent vision loss due to retinal pigme...
Eligibility Criteria
Inclusion
- Patients with vascular PED due to AMD
- Male or female patients with the age \> 50 years
- Angiographic and via OCT ensured PED ≥ 200 µm in the eye for treatment
- Written informed consent
- Best corrected visual acuity (ETDRS-Visus): 24 - 73 letters within
Exclusion
- Patients that do not fulfill the a. m. inclusion criteria
- Patients which have been treated with steroids or with verteporfin via photodynamic therapy or focal lasercoagulation treatment until 3 months before,
- Anti VEGF therapy until 1 month before screening
- Patients with other retinal vascular diseases including diabetic rethinopathia or retinal vein occlusion
- Other ocular operative procedurs 3 months before Screening
- Anamnesis of non controlled glaucoma
- Active or intraocular Inflammation or Inflammation of ocular adnexa
- Subfoveal fibrosis within study eye
- Larger surgical interventions 1 month before Screening
- Anamnesis of serious cardiovascular diseases or stroke 6 months before srceening
- Allergy of components of the study medication
- Patients which might be not compliant
- Patients participating at another clinical trial at the same time
- Pregnancy, breastfeeding, women in child-bearing years without using a safe contraception method
- Chronical alcohol- or drug abuse within the last year
- lack of capacity and/or knowledge of German language
- Neurologic disease i. e. multiple sclerosis
Key Trial Info
Start Date :
April 17 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 23 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03370380
Start Date
April 17 2015
End Date
April 23 2018
Last Update
August 6 2018
Active Locations (1)
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1
University Hospital Muenster
Münster, Germany, 48149