Skip to main content
OpenTrials
Completed

NCT Number: NCT03370380

Aflibercept in Patients With Pigment Epithelial Detachments (PED)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pigment Epithelial Detachment Eye Diseases Retinal Detachment Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Muenster

Münster, 48149, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug

Patients are treated according to authorization of Aflibercept

Primary outcomes

  1. Retention and improvement of visual acuity

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

    Visual acuity after treatment completion compared to baseline

  2. Height of Pigment Epithel Detachment

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

    The height of PED after treatment completion compared to baseline

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

Intravitreal Aflibercept in Patients With Retinal Pigment Epithelial Detachment (PED) Secondary to Age Related Macular Degeneration (AMD)

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 12, 2017
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.