Aflibercept in Patients With Pigment Epithelial Detachments (PED)

August 3, 2018 updated by: University Hospital Muenster

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenster, Germany, 48149
        • University hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Screening until 1 month after last injection within study eye (Month 12)
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
Screening until 1 month after last injection within study eye (Month 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Christoph Clemens, Dr. med., University hospital Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2015

Primary Completion (Actual)

April 23, 2018

Study Completion (Actual)

April 23, 2018

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMD-PEA 14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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