Clinical trial NCT03370380: Aflibercept in Patients With Pigment Epithelial Detachments (PED)
Official title: Intravitreal Aflibercept in Patients With Retinal Pigment Epithelial Detachment (PED) Secondary to Age Related Macular Degeneration (AMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pigment Epithelial Detachment
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In total 20 eyes/patients are treated and observed after inclusion diagnosis and informed consent over a period about 1 year.

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


Eligibility criteria: 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

Primary outcomes:
measure: Retention and improvement of visual acuity
timeFrame: Screening until 1 month after last injection within study eye (Month 12)
measure: Height of Pigment Epithel Detachment
timeFrame: Screening until 1 month after last injection within study eye (Month 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: University Hospital Muenster
name: Christoph Clemens, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clemens CR, Alten F, Termuhlen J, Mihailovic N, Rosenberger F, Heiduschka P, Eter N. Prospective PED-study of intravitreal aflibercept for refractory vascularized pigment epithelium detachment due to age-related macular degeneration: morphologic characteristics of non-responders in optical coherence tomography. Graefes Arch Clin Exp Ophthalmol. 2020 Jul;258(7):1411-1417. doi: 10.1007/s00417-020-04675-y. Epub 2020 Apr 18.