Maximum Treatment Interval With Aflibercept T&E
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
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedApril 25, 2022
April 1, 2022
2.6 years
April 5, 2022
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The percentage of patients whose maximum treatment interval is extended to 24 months
2 years
Secondary Outcomes (8)
Find the prediction factors associated with extension to 16 weeks and beyond by univariate and multivariate analysis
2 years
Find the prediction factors associated with occurrence of disease activity by univariate and multivariate analysis
2 years
The percentage of patients whose maximum treatment interval is extended to 16 weeks and beyond in 24 months in PCV and wAMD subgroup
2 years
Mean change in BCVA from baseline to month 24
2 years
Mean change in central subfield thickness from baseline to month 24
2 years
- +3 more secondary outcomes
Interventions
Aflibercept 2.0 mg with the T\&E criteria in Taiwan local consensus
Eligibility Criteria
Treatment-naïve nAMD and PCV patients
You may qualify if:
- Treatment-naïve patients with subfoveal CNV secondary to wet AMD and PCV, with visual impairment being exclusively due to an symptomatic neovascular AMD.
- \- -Clinical status meet the national reimbursement criteria
You may not qualify if:
- \- Any contraindications as listed in the local intravitreal aflibercept package insert
- \- Any active periocular or ocular infection or inflammation at baseline
- \- Uncontrolled glaucoma (intraocular pressure \[IOP\] ≥30 mm Hg on medication) at baseline
- \- Neovascularisation of the iris or neovascular glaucoma at baseline
- \- Visually significant cataract, severe vitreous haemorrhage, rhegmatogenous retinal detachment, proliferative diabetic retinopathy or CNV of any cause other than wet AMD at baseline
- \- Structural damage to the center of the macula in either eye that is likely to preclude improvement in VA following the resolution of macular edema or any other condition expected to permanently limit VA outcomes over the course of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shin Kong Memorial Wu Ho-Su Hospital
Taipei, Taiwan
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 25, 2022
Study Start
January 1, 2022
Primary Completion
August 1, 2024
Study Completion
April 1, 2025
Last Updated
April 25, 2022
Record last verified: 2022-04