Macular Degeneration, Retinal Detachment
Conditions
Keywords
Angiogenesis inhibitors, Photochemotherapy, Vascular Endothelium Growth Factors, Aflibercept
Brief 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.
Interventions
DRUGAflibercept
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.
DRUGVerteporfin
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.
Sponsors
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in visual acuity from baseline to 24 months | 24 months | Best corrected visual acuity (BCVA) on the Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at 4 meters will be compared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity from baseline to 6 months | 6 months | BCVA on ETDRS will be compared from baseline to 6 months |
| Visual acuity from baseline to 12 months | 12 months | BCVA on ETDRS will be compared from baseline to 12 months |
| Safety | 24 months | Incidence and severity of ocular and non-ocular adverse events will be evaluated through 24 months |
| Change in Optical Coherence Tomography (OCT) measurements from baseline through 24 months | 24 months | Change in OCT Central Retinal Thickness (CRT) and Volume of PED from baseline through 24 months |
| Development of choroidal neovascularisations (CNV) | 24 months | Development of CNV seen with OCT, fluorescein and indocyanine green imaging |
Countries
Norway
Outcome results
None listed