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Primary Objectives:
To assess the efficacy of intravitreal administered Eylea in preventing visual loss in subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared to Baseline.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eylea | Other | The intravitreal dose of Eylea will be 2mg (50ul) per injection. The medication will be supplied in single use vials. Given monthly for 3 months and then every 8 weeks until week 52. This is an open-label study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eylea | Drug | monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of Eylea in patients with RPED | visual acuity mean change from baseline compared to month 12 | baseline to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of repeated Eylea injection | assessment of adverse events at each visit | period of 1 year |
| effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ivey Eye Institute | London | Ontario | N6A 4V2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31564356 | Derived | Diaconita V, Li B, Pal L, Bahnacy F, Gonder JR. Prospective evaluation of aflibercept in pigment epithelial detachments secondary to neovascular age related macular degeneration. Can J Ophthalmol. 2019 Oct;54(5):626-634. doi: 10.1016/j.jcjo.2019.01.004. Epub 2019 Apr 3. |
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using OCT (optical coherence tomography) thickness, volume and height will be compared from baseline to month 12
| baseline to month 12 |
| effect of repeated Eyle injections on vision related quality of life | using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12 | baseline to month 12 |
| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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