Status:
UNKNOWN
Maximum Treatment Interval With Aflibercept T&E
Lead Sponsor:
Shin Kong Wu Ho-Su Memorial Hospital
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
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 ...
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 ...
Eligibility Criteria
Inclusion
- -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
Exclusion
- \- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05342857
Start Date
January 1 2022
End Date
April 1 2025
Last Update
April 25 2022
Active Locations (1)
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1
Shin Kong Memorial Wu Ho-Su Hospital
Taipei, Taiwan