Pigment Epithelial Detachment
Conditions
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 pigment epithelial detachment secondary to AMD
Interventions
DRUGAflibercept
Patients are treated according to authorization of Aflibercept
Sponsors
University Hospital Muenster
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention and improvement of visual acuity | Screening until 1 month after last injection within study eye (Month 12) | Visual acuity after treatment completion compared to baseline |
| Height of Pigment Epithel Detachment | Screening until 1 month after last injection within study eye (Month 12) | The height of PED after treatment completion compared to baseline |
Countries
Germany
Outcome results
None listed