Aflibercept in Patients With Pigment Epithelial Detachments (PED)

NCT03370380 | Completed

• 1 other identifier: AMD-PEA 14
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Pigment Epithelial Detachment

Outcome Measures

Primary Outcomes (2)

• Retention and improvement of visual acuity

  Visual acuity after treatment completion compared to baseline

  Screening until 1 month after last injection within study eye (Month 12)

• Height of Pigment Epithel Detachment

  The height of PED after treatment completion compared to baseline

  Screening until 1 month after last injection within study eye (Month 12)

Interventions

Aflibercept DRUG

Patients are treated according to authorization of Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, 48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 32306096 DERIVED

MeSH Terms

Conditions

Retinal Detachment

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Christoph Clemens, Dr. med.

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 12, 2017
• Study Start: April 17, 2015
• Primary Completion: April 23, 2018
• Study Completion: April 23, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)