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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
9
2.0 mg monthly x 3 doses, then as needed based on recurrence of activity on OCT. If no effect after the initial 3 doses; 2.0 mg monthly x 3 doses is repeated.
given if aflibercept does not have any effect. Verteporfin photodynamic therapy is given in combination with aflibercept and triamcinolone. The treatment can be repeated after 3 month.
Department of Neuroscience, NTNU
Trondheim, Norway
Mean change in visual acuity from baseline to 24 months
Best corrected visual acuity (BCVA) on the Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at 4 meters will be compared
Time frame: 24 months
Visual acuity from baseline to 6 months
BCVA on ETDRS will be compared from baseline to 6 months
Time frame: 6 months
Visual acuity from baseline to 12 months
BCVA on ETDRS will be compared from baseline to 12 months
Time frame: 12 months
Safety
Incidence and severity of ocular and non-ocular adverse events will be evaluated through 24 months
Time frame: 24 months
Change in Optical Coherence Tomography (OCT) measurements from baseline through 24 months
Change in OCT Central Retinal Thickness (CRT) and Volume of PED from baseline through 24 months
Time frame: 24 months
Development of choroidal neovascularisations (CNV)
Development of CNV seen with OCT, fluorescein and indocyanine green imaging
Time frame: 24 months
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