Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-17 @ 4:42 PM
Study NCT ID:
NCT06683950
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Switching to Aflibercept 8mg in Patients Showing Limited Response to Previous Treatment
Sponsor:
Kim's Eye Hospital
Organization:
Study Overview
Official Title:
Efficacy of Switching to Aflibercept 8mg in Patients with Neovascular AMD Showing Limited Response to Faricimab or Aflibercept 2mg
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The treatment landscape for neovascular AMD has evolved with various anti-VEGF agents since 2006. Ranibizumab initially led the way, but its limited efficacy in reducing retinal edema paved the way for aflibercept in 2011, which became globally popular for its effectiveness and safety. Yet, aflibercept did not fully meet all patients' needs. In 2019, brolucizumab showed promising anatomical results but had higher risks of inflammation, limiting its use. Faricimab, introduced in 2022, aimed for longer-lasting effects by targeting VEGF-A and angiopoietin 2. Though it required fewer injections, questions remain about its long-term efficacy compared to aflibercept.
Despite recent advancements, no agent has established itself as the new standard since aflibercept's introduction, leaving significant unmet needs. Aflibercept 8mg, approved in 2023, has shown promise by matching long-term visual outcomes of aflibercept 2mg with fewer injections and comparable safety. This study examines the effects of switching to aflibercept 8mg for patients with a limited response to previous treatments, addressing the potential for aflibercept 8mg to meet current needs more effectively and providing timely data for its global rollout.
Despite recent advancements, no agent has established itself as the new standard since aflibercept's introduction, leaving significant unmet needs. Aflibercept 8mg, approved in 2023, has shown promise by matching long-term visual outcomes of aflibercept 2mg with fewer injections and comparable safety. This study examines the effects of switching to aflibercept 8mg for patients with a limited response to previous treatments, addressing the potential for aflibercept 8mg to meet current needs more effectively and providing timely data for its global rollout.
Detailed Description:
The treatment of neovascular AMD with anti-VEGF agents has evolved significantly. Introduced in 2006, ranibizumab heralded the era of anti-VEGF therapies but had limitations in duration and effectiveness in reducing retinal edema. To overcome these issues, aflibercept was introduced in 2011 and has been recognized for its superior efficacy and safety,1 becoming the most widely used drug globally. However, aflibercept also showed limited response in some patients, and the duration of its effectiveness was not always satisfactory.
Brolucizumab, introduced in 2019, demonstrated excellent anatomical outcomes but had a relatively high incidence of intraocular inflammation, ranging from 3 to 10%, preventing it from becoming a widely accepted standard treatment. The most recent, faricimab, introduced in 2022, was developed to inhibit not only VEGF-A but also angiopoietin 2, aiming for longer-lasting effects. In the TENAYA/LUCERNE clinical trials comparing its efficacy and safety with aflibercept, faricimab showed similar effects with fewer injections. However, due to differences in the treatment protocols between the aflibercept and faricimab groups, there remains a question about whether faricimab truly offers a longer duration of effect.
In conclusion, despite the introduction of brolucizumab and faricimab over the long span of 13 years since aflibercept was first introduced, these drugs have struggled to establish themselves as the new standard agents, especially when considering their overall efficacy and safety. Consequently, there has been a significant accumulation of unmet needs in the clinical treatment landscape over this extended period.
Aflibercept 8mg, the most recently FDA-approved agent in 2023, demonstrated not only superior initial anatomical effects compared to aflibercept 2mg in the PULSAR study, but also achieved similar long-term visual outcomes with fewer injections. Furthermore, it exhibited excellent safety, comparable to that of aflibercept 2mg. Based on these outcomes, many experts anticipate that aflibercept 8mg will become the new standard agent in the treatment of neovascular AMD, officially succeeding aflibercept 2mg.
Excluding aflibercept 2mg, faricimab could be considered the strongest contender for establishing aflibercept 8mg as the new standard. This is attributed to faricimab demonstrating satisfactory effects and excellent safety in clinical trials, as well as in subsequent real-world studies. Currently, there are no head-to-head clinical trials comparing these two drugs, and even if such trials are planned, it would take a considerable amount of time to ascertain the results. However, there is a simpler method to compare the effectiveness of a new agent against existing ones, which involves evaluating the effects of switching treatment in patients who have shown limited response to the current medication. In fact, such switching to new pharmaceutical agents after their introduction is widely practiced in clinical settings.10 Historically, the excellent efficacy observed when switching from ranibizumab to aflibercept 2mg played a significant role in the widespread adoption of aflibercept 2mg.
In this study, investigators aimed to evaluate the effects of switching to aflibercept 8mg in patients who have shown limited response to previous faricimab or aflibercept 2mg treatment. To the best of our knowledge, no such study has been reported in the English literature so far. This study not only has the potential to highlight the extended duration of action of aflibercept 8mg, but also holds significant importance in addressing the current unmet needs in the treatment of neovascular AMD. Additionally, by completing the study in a short period, investigators can contribute to generating timely data that aligns with the global introduction of aflibercept 8mg.
Brolucizumab, introduced in 2019, demonstrated excellent anatomical outcomes but had a relatively high incidence of intraocular inflammation, ranging from 3 to 10%, preventing it from becoming a widely accepted standard treatment. The most recent, faricimab, introduced in 2022, was developed to inhibit not only VEGF-A but also angiopoietin 2, aiming for longer-lasting effects. In the TENAYA/LUCERNE clinical trials comparing its efficacy and safety with aflibercept, faricimab showed similar effects with fewer injections. However, due to differences in the treatment protocols between the aflibercept and faricimab groups, there remains a question about whether faricimab truly offers a longer duration of effect.
In conclusion, despite the introduction of brolucizumab and faricimab over the long span of 13 years since aflibercept was first introduced, these drugs have struggled to establish themselves as the new standard agents, especially when considering their overall efficacy and safety. Consequently, there has been a significant accumulation of unmet needs in the clinical treatment landscape over this extended period.
Aflibercept 8mg, the most recently FDA-approved agent in 2023, demonstrated not only superior initial anatomical effects compared to aflibercept 2mg in the PULSAR study, but also achieved similar long-term visual outcomes with fewer injections. Furthermore, it exhibited excellent safety, comparable to that of aflibercept 2mg. Based on these outcomes, many experts anticipate that aflibercept 8mg will become the new standard agent in the treatment of neovascular AMD, officially succeeding aflibercept 2mg.
Excluding aflibercept 2mg, faricimab could be considered the strongest contender for establishing aflibercept 8mg as the new standard. This is attributed to faricimab demonstrating satisfactory effects and excellent safety in clinical trials, as well as in subsequent real-world studies. Currently, there are no head-to-head clinical trials comparing these two drugs, and even if such trials are planned, it would take a considerable amount of time to ascertain the results. However, there is a simpler method to compare the effectiveness of a new agent against existing ones, which involves evaluating the effects of switching treatment in patients who have shown limited response to the current medication. In fact, such switching to new pharmaceutical agents after their introduction is widely practiced in clinical settings.10 Historically, the excellent efficacy observed when switching from ranibizumab to aflibercept 2mg played a significant role in the widespread adoption of aflibercept 2mg.
In this study, investigators aimed to evaluate the effects of switching to aflibercept 8mg in patients who have shown limited response to previous faricimab or aflibercept 2mg treatment. To the best of our knowledge, no such study has been reported in the English literature so far. This study not only has the potential to highlight the extended duration of action of aflibercept 8mg, but also holds significant importance in addressing the current unmet needs in the treatment of neovascular AMD. Additionally, by completing the study in a short period, investigators can contribute to generating timely data that aligns with the global introduction of aflibercept 8mg.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: