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Study of efficacy of aflibercept in neovascular age-related macular degeneration (wAMD) with non-responder of ranibizumab

Study of efficacy of aflibercept in neovascular age-related macular degeneration (wAMD) with non-responder of ranibizumab - Study of aflibercept in wAMD with non-responder of ranibizumab

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010577
Enrollment
50
Registered
2013-04-26
Start date
2013-04-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related macular degeneration

Interventions

aflibercept

Sponsors

Nagoya City University Graduate School of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Willingness to provide written informed consent 2) Subfoveal CNV secondary to AMD on OCT 3) History treatment with ranibizumab for wAMD 4) Decimal BCVA > 0.05 5) The first ranibizumab treatment was within the past 12 months from the first injection of aflibercept 6) Non-responder of ranibizumab (ranibizumab treatments > 4, VA gain at least once with ranibizumab treatment, persistent fluid on OCT after each the last 2 injections of ranibizumab, No VA gain)

Exclusion criteria

Exclusion criteria: 1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas 2) Prior treatment with photodynamic therapy (PDT) within the past 3 months or more than 4 prior PDT treatment 3) Presence of RPE tears, or subretinal hemorrhage, scar or macular fibrosis (>50% lesion area area) 4) Prior treatment with aflibercept 5) Prior treatment with triamcinolone within 6 months 6) Prior treatment with dexamethasone within 30 days 7) Intraocular surgery within 6 months, vitrectomy surgery, submacular surgery, or other surgical intervention for AMD 8) Active intraocular inflammation 9) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products

Design outcomes

Primary

MeasureTime frame
Macula fluid on OCT at month 3

Secondary

MeasureTime frame
Change of BCVA, central macular thickness

Countries

Japan

Contacts

Public ContactTsutomu Yasukawa

Nagoya City University Graduate School of Medical Sciences Department of Ophthalmology and Visual Science

yasukawa@med.nagoya-cu.ac.jp052-053-8251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026