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The purpose of this study is to assess a new treatment pattern for aflibercept. The aim is to achieve and maintain the best benefit of visual function and avoid unnecessary hospital visits.
The hypothesis to be tested is whether intravitreous aflibercept given in an 8 week cycle of treatment in year 1 and a capped treat and extend treatment paradigm in year 2 can lead to improved vision and reading speed in eyes with active wet AMD over 2 years while reducing hospital visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eylea Treatment | Other | The intravitreal dose of Eylea will be 2mg (in 0.05ml) per injection. The medication will be supplied in single use vials. Given monthly for 3 months and then every 8 weeks in the first year of treatment before applying a treat and extend paradigm to patient visits in year 2. This is an open-label study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug |
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| Extend Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome - mean change in visual acuity (Early Treatment of Diabetic Retinopathy Study letter score) | The primary outcome is the mean change in visual acuity (Early Treatment of Diabetic Retinopathy Study letter score) at 24 months from baseline. | 24 months |
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Inclusion Criteria:
Study eyes must meet the following criteria for entry into the trial and must have vision loss accounted for by wet AMD:
Exclusion Criteria:
Subjects who meet the following criteria will be excluded from study participation:
6.2.1 Prior/Concomitant Treatment
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| Name | Affiliation | Role |
|---|---|---|
| Praveen Patel, MD | Moorfields Eye Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Hospital NHS Foundation Trust | London | EC1V 2PD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32557168 | Derived | Patel PJ, Jayaram H, Eleftheriadou M, Vazquez-Alfageme C, Islam N, Rubin GS, Pal B, Addison PK, Hamilton R, Degli Esposti S. Individualizing Therapy for Neovascular Age-Related Macular Degeneration with Aflibercept (VITAL): A Two-Year Prospective, Interventional Single-Centre Trial. Ophthalmol Ther. 2020 Sep;9(3):563-576. doi: 10.1007/s40123-020-00267-5. Epub 2020 Jun 18. |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Other |
In year 2 of the study a treat and extend protocol will be applied, if a patient has signs of disease activity (eg macular fluid on SDOCT) they will be brought back at 8 weeks after the visit and given an intravitreous injection. They will then be reviewed 8 weeks post treatment for a further treatment with follow-up and treatment interval extended to 10 weeks if the disease is quiescent (if no macular fluid at the subsequent visit the patient could be extended to 12 weeks interval with treatment). |
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