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Aflibercept in Patients With Pigment Epithelial Detachments (PED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370380
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

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

Condition or disease Intervention/treatment
Pigment Epithelial Detachment Drug: Aflibercept

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Intravitreal Aflibercept in Patients With Retinal Pigment Epithelial Detachment (PED) Secondary to Age Related Macular Degeneration (AMD)
Actual Study Start Date : April 17, 2015
Actual Primary Completion Date : April 23, 2018
Actual Study Completion Date : April 23, 2018



Intervention Details:
  • Drug: Aflibercept
    Patients are treated according to authorization of Aflibercept


Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370380


Locations
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Germany
University Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Christoph Clemens, Dr. med. University Hospital Muenster
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT03370380    
Other Study ID Numbers: AMD-PEA 14
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases