Aflibercept in Patients With Pigment Epithelial Detachments (PED)

University Hospital Muenster

Status: Completed

Conditions: Pigment Epithelial Detachment

Treatments: Drug: Aflibercept

Study type: Observational

Funder types: Other

Identifiers

NCT03370380

AMD-PEA 14

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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