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treatment effects not as desired
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Observation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tor Elsaas, Prof. MD | Norwegian University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neuroscience, NTNU | Trondheim | 7489 | Norway |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000077362 | Verteporfin |
| ID | Term |
|---|---|
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| Verteporfin | Drug | 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. |
|
| 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 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |