Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-01 @ 7:16 PM
Study NCT ID:
NCT05342857
Status:
UNKNOWN
Last Update Posted:
2022-04-25
First Post:
2022-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maximum Treatment Interval With Aflibercept T&E
Sponsor:
Shin Kong Wu Ho-Su Memorial Hospital
Organization:
Study Overview
Official Title:
Investigation of the Maximal Treatment Interval and Long-term Remission and the Associated Factors of Neovascular AMD Treated With Anti-VEGF Using Treat and Extend Strategy
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
To evaluate the duration of effectiveness of anti-VEGF (Aflibercept) by analyzing the percentage of patients whose maximum treatment interval is extended to 16 weeks and beyond in 24 months and their long-term remission.
Detailed Description:
This is an Observational, prospective, single arm study. The distribution of maximum treatment interval extended within 2 year among nAMD patients with Aflibercept Treat-and-Extend(T\&E) regimen will be analyzed. And Clinical indicators for fast extension of treatment interval and emering disease activity will be captured.
To maximize Vision acuity (VA) outcome and reduce treatment burden of neovascular age-related macular degeneration (nAMD) patients, the T\&E regimen has become popular in recent years. Sufficient drug durability is the key element to support T\&E regimen. Clinical trials with aflibercept suggest a longer duration of VEGF suppression than with bevacizumab or ranibizumab, which is also supported by pharmacokinetic models, and mean duration of vitreous VEGF suppression by aflibercept injection was demonstrated as \> 71 ± 18 days. With these attributes, while managed by intravitreal injection aflibercept (IVI-ALF) T\&E regimen, it has been shown in ALTAIR study that around 40% and 60% of patients had treatment interval extended to 12 week and 16 weeks at week 96 respectively.
Nevertheless, it was observed that the distribution of treatment interval is polarized, a group of patients would eventually reach a stable disease status with only few treatments needed per year, while another group of patients may still need more intensive treatment even shorter than 8 week interval. To maximize benefit of patients with practical and personalized IVT-AFL T\&E regimens, it is important to provided further evidence to support maximizing treatment interval as well as clinical indicators to take precise action to active disease. Therefore, this study is designed to understand the potential durability of Aflibercept by analyzing maximum treatment interval with IVT-AFL in 2 years, and explore clinical indicators to guide optimal T\&E regimen for each patient.
Patients are treated with Aflibercept 2.0 mg following the T\&E criteria in Taiwan local consensus (listed as below). Once the treatment interval is extended to 16 weeks, and the patient has two consecutive 16-week treatment interval, treatment strategy will be changed to pro re nata (PRN) with monthly follow-up. IVI-AFL will immediately be applied once there is any disease activity detected.
During the study, patients will be monitored with BCVA, fundus photograph, structural OCT, OCT Angiography.
T\&E criteria in Taiwan local consensus:
* Extension: No BCVA loss ≥ 5 ETDRS letters (or 1 line of Snellen chart) AND dry retina§,†, #
* Maintain: No BCVA loss ≥ 5 ETDRS letters (or 1 line of Snellen chart) AND non-increased fluid§
* Shortening: Any increased fluid with BCVA loss ≥ 5 ETDRS letters (or 1 line of Snellen chart)‡, # OR new macular hemorrhage OR new neovascularization
"§"Absence of macular hemorrhage and neovascularization is required.
"†"Non-increased fluid after 3 more consecutive monthly injections following initial treatment could be considered as persistent fluid, and the injection interval could be extended if VA is stable.
"‡" Either increased fluid or BCVA loss ≥ 5 ETDRS letters alone could be maintained at current treatment interval.
"#" Extension or shortening can be by 2 or 4 weeks
To maximize Vision acuity (VA) outcome and reduce treatment burden of neovascular age-related macular degeneration (nAMD) patients, the T\&E regimen has become popular in recent years. Sufficient drug durability is the key element to support T\&E regimen. Clinical trials with aflibercept suggest a longer duration of VEGF suppression than with bevacizumab or ranibizumab, which is also supported by pharmacokinetic models, and mean duration of vitreous VEGF suppression by aflibercept injection was demonstrated as \> 71 ± 18 days. With these attributes, while managed by intravitreal injection aflibercept (IVI-ALF) T\&E regimen, it has been shown in ALTAIR study that around 40% and 60% of patients had treatment interval extended to 12 week and 16 weeks at week 96 respectively.
Nevertheless, it was observed that the distribution of treatment interval is polarized, a group of patients would eventually reach a stable disease status with only few treatments needed per year, while another group of patients may still need more intensive treatment even shorter than 8 week interval. To maximize benefit of patients with practical and personalized IVT-AFL T\&E regimens, it is important to provided further evidence to support maximizing treatment interval as well as clinical indicators to take precise action to active disease. Therefore, this study is designed to understand the potential durability of Aflibercept by analyzing maximum treatment interval with IVT-AFL in 2 years, and explore clinical indicators to guide optimal T\&E regimen for each patient.
Patients are treated with Aflibercept 2.0 mg following the T\&E criteria in Taiwan local consensus (listed as below). Once the treatment interval is extended to 16 weeks, and the patient has two consecutive 16-week treatment interval, treatment strategy will be changed to pro re nata (PRN) with monthly follow-up. IVI-AFL will immediately be applied once there is any disease activity detected.
During the study, patients will be monitored with BCVA, fundus photograph, structural OCT, OCT Angiography.
T\&E criteria in Taiwan local consensus:
* Extension: No BCVA loss ≥ 5 ETDRS letters (or 1 line of Snellen chart) AND dry retina§,†, #
* Maintain: No BCVA loss ≥ 5 ETDRS letters (or 1 line of Snellen chart) AND non-increased fluid§
* Shortening: Any increased fluid with BCVA loss ≥ 5 ETDRS letters (or 1 line of Snellen chart)‡, # OR new macular hemorrhage OR new neovascularization
"§"Absence of macular hemorrhage and neovascularization is required.
"†"Non-increased fluid after 3 more consecutive monthly injections following initial treatment could be considered as persistent fluid, and the injection interval could be extended if VA is stable.
"‡" Either increased fluid or BCVA loss ≥ 5 ETDRS letters alone could be maintained at current treatment interval.
"#" Extension or shortening can be by 2 or 4 weeks
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: