Overview

A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes

Status:
Terminated
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine treatment effects in patients with retinal pigment epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with newly diagnosed PED without choroidal neovascularisations (CNV), will be randomized to either treatment or observation. The treatment group will first be given injections with anti Vascular Endothelium Growth Factor (anti-VEGF). If the injections do not have any effect, Verteporfin Photodynamic Therapy (PDT) will be given. All patients will be followed for a period of 2 years. It is hypothesized that treatment stops the progression of the disease and stabilizes the vision in this subgroup of patients with AMD.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Norwegian University of Science and Technology
Treatments:
Aflibercept
Verteporfin
Criteria
Inclusion Criteria:

- Ability to provide written informed consent and comply with study assessments for the
full duration of the study

- Age > 50 years

- Pigment epithelium detachment in an eye not earlier treated with anti-VEGF or
verteporfin PDT.

- ETDRS Best Corrected Visual acuity 20/32 - 20/400

Exclusion Criteria:

- Prior treatment with verteporfin, or external-beam radiation therapy, or
transpupillary thermotherapy, Previous subfoveal focal laser photocoagulation
involving the foveal center, History of vitrectomy, submacular surgery, or other
surgical intervention for AMD.

- CNV, Subfoveal fibrosis or atrophy in study eye.

- Concurrent eye disease in the study eye that could compromise visual acuity (e.g.,
diabetic retinopathy, advanced glaucoma) or require medical or surgical intervention
during the study. Active intraocular inflammation in the study eye.