Aflibercept in Patients With Pigment Epithelial Detachments (PED)

Pigment Epithelial Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370380
• Other study ID #: AMD-PEA 14
• Status: Completed
• Start date: April 17, 2015
• Est. completion date: April 23, 2018

Study information

• Verified date: July 2018
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 23, 2018
• Est. primary completion date: April 23, 2018
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Pigment Epithelial Detachment
• Retinal Detachment

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)