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

Study Overview
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Brief Summary
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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.

Official Title
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Pigment Epithelium Detachment - a Prospective Clinical Study. PED-study.

Conditions
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Macular Degeneration, Retinal Detachment

Intervention / Treatment
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* Drug: Aflibercept
* Drug: Verteporfin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Drug: Aflibercept<br>* 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.<br>Drug: Verteporfin<br>* 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.<br>|
| No Intervention: Observation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity from baseline to 6 months | BCVA on ETDRS will be compared from baseline to 6 months | 6 months | 
| Visual acuity from baseline to 12 months | BCVA on ETDRS will be compared from baseline to 12 months | 12 months | 
| Safety | Incidence and severity of ocular and non-ocular adverse events will be evaluated through 24 months | 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 | 24 months | 
| Development of choroidal neovascularisations (CNV) | Development of CNV seen with OCT, fluorescein and indocyanine green imaging | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiogenesis inhibitors, Photochemotherapy, Vascular Endothelium Growth Factors, Aflibercept