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

Norwegian University of Science and Technology

Status: Terminated

Conditions: Retinal Detachment; Macular Degeneration

Treatments: Drug: Aflibercept; Drug: Verteporfin

Study type: Interventional

Funder types: Other

Identifiers

NCT01746875

2012/1743

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Treatment

Experimental group

Description:

aflibercept intravitreal injections, 2.0 mg monthly x 3 doses, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; aflibercept intravitreal injections, 2.0 mg x 3 doses is repeated, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; verteporfin photo dynamic therapy.

Treatment:

Drug: Verteporfin

Drug: Aflibercept

Observation

No Intervention group