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Study of visual and anatomical outcomes of second year aflibercept in good visual acuity baseline of wet age-related macular degeneration

Study of visual and anatomical outcomes of second year aflibercept in good visual acuity baseline of wet age-related macular degeneration - Study of second year aflibercept in patients with wAMD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016598
Enrollment
42
Registered
2015-02-22
Start date
2015-02-22
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

Sponsors

Department of Ophthalmology, Jichi Medical University
Lead Sponsor
JCHO Tokyo Shinjuku Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) baseline BCVA in the study eye over 0.5 (Decimal VA) 2) AMD with Subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography 3) Willingness to provide written informed consent 4) outpatient 5) second year aflibercept treatment

Exclusion criteria

Exclusion criteria: 1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas 2) Presence of subretinal hemorrhage, scar or macular fibrosis (>50% lesion area) 3) Prior treatment with anti-VEGF drug, photodynamic therapy 4) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months) 5) Active intraocular inflammation 6) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products 7) Patient who the doctor in charge judges are ineligible for the study

Design outcomes

Primary

MeasureTime frame
Change of best-collected visual acuity and proportion of improved, maintained and deteriorated visual acuity at month 24 from 12 after initial injection of aflibercept

Secondary

MeasureTime frame
Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid and polyps regression

Countries

Japan

Contacts

Public ContactHidenori Takahashi

Jichi Medical University Department of Ophthalmology

takahah-tky@umin.ac.jp0285-58-7382

Outcome results

None listed

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