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| Name | Class |
|---|---|
| medignition AG | UNKNOWN |
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The currently widely established and preferred protocol for the treatment of wet age-related macular degeneration includes a loading phase of three monthly injections without interim adaptation or treatment according to disease activity, thereafter following a T&E strategy with treatment adaptation in increments of 2-4 weeks according to disease activity. Based on pharmacological considerations regarding the vitreal half-life of the drugs, the aim of this prospective explorative study is to test whether an early extension of treatment intervals without a loading phase is an option without compromising functional outcomes. Based on a superiority of Afl compared to Ran with regard to achieving a dry retina after one year and based on studies, but in the absence of real-life experience with Bro, it seems of interest to test how far Afl and Bro are comparable in terms of their potential to extend the treatment intervals over 12 months, the time to dryness of the retina, and number of injections. Also, it is of high clinical relevance to demonstrate efficacy with longer initial treatment intervals compared to the current possibly over-treating loading-phase with three four-weekly injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept ® rapid treatment extension (T&E) | Active Comparator | Early treat and extend (T&E) with Aflibercept ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments. |
|
| Brolucizumab ® rapid treatment extension (T&E) | Active Comparator | Early treat and extend (T&E) with Brolucizumab ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | administration of anti-VEGF Aflibercept (Eylea) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of injections given until week 52 | number injections received by patient | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Injections until week 104 | number injections received by patient | 104 weeks |
| Number of treatment failures | number with treatment demand of less than 6 weeks at any time point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justus G. Garweg, Prof. Dr. med. | Berner Augenklinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berner Augenklinik | Bern | 3007 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24879948 | Background | Fauser S, Schwabecker V, Muether PS. Suppression of intraocular vascular endothelial growth factor during aflibercept treatment of age-related macular degeneration. Am J Ophthalmol. 2014 Sep;158(3):532-6. doi: 10.1016/j.ajo.2014.05.025. Epub 2014 May 28. | |
| 33528645 | Background | Garweg JG, Gerhardt C. Disease stability and extended dosing under anti-VEGF treatment of exudative age-related macular degeneration (AMD) - a meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2021 Aug;259(8):2181-2192. doi: 10.1007/s00417-020-05048-1. Epub 2021 Feb 2. |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| C000622091 | brolucizumab |
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two-armed, randomized, double-blind
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double-blind
| Brolucizumab | Drug | administration of anti-VEGF Brolucizumab (Beovu) |
|
| early treat and extend (T&E) | Procedure | extension of treatment intervals (T&E) from the beginning of treatment |
|
| 52 weeks |
| Number of treatment failures | number with treatment demand of less than 6 weeks at any time point | 104 weeks |
| Time until drying of retina | mean interval until absence of intra- and subretinal fluid | 52 weeks |
| Time until drying of retina | mean interval until absence of intra- and subretinal fluid | 104 weeks |
| portion of eyes without disease activity | % patients with absence of intra- and subretinal fluid | 52 weeks |
| portion of eyes without disease activity | % patients with absence of intra- and subretinal fluid | 104 weeks |
| eyes under treatment intervals of ≥12 weeks | portion of eyes with stable disease under treatment intervals of ≥12 weeks | 52 weeks |
| eyes under treatment intervals of ≥12 weeks | portion of eyes with stable disease under treatment intervals of ≥12 weeks | 104 weeks |
| Change in visual acuity | change of VA in logRAD from baseline to week 52 | 52 weeks |
| Change in visual acuity | change of VA in logRAD from baseline to week 104 | 104 weeks |
| Change in central subfield thickness (CST) | change from baseline to week 52 | 52 weeks |
| Change in central subfield thickness (CST) | change from baseline to week 104 | 104 weeks |
| Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters | change from baseline to week 52 | 52 weeks |
| Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters | change from baseline to week 104 | 104 weeks |
| Maximal treatment interval extension | mean treatment interval extension | 52 weeks |
| Maximal treatment interval extension | mean treatment interval extension | 104 weeks |