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The Change of focal macular electroretinogram(ERG) in patients with age-related macular degeneration after intravitreal aflibercept(IVA).

The Change of focal macular electroretinogram(ERG) in patients with age-related macular degeneration after intravitreal aflibercept(IVA). - Focal macular ERG with wAMD sfter IVA.

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023590
Enrollment
50
Registered
2016-08-15
Start date
2016-05-20
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

Eylea(aflibercept)

Sponsors

Dokkyo Medical University, Koshigaya Hospital Department of Ophthalmology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) BCVA:0.1-1.0 2) naive AMD with subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography 3) Willingness to provide written informed consent 4) outpatients

Exclusion criteria

Exclusion criteria: 1) Patients with any previous history of treatment of other retinal diseases with pharmacologic agents including verteporfin photodynamic therapy, aflibercept, ranibizumab, bevacizumab or steroids. 2) Clinically significant drug allergy. 3) History of vitrectomy or glaucoma surgery. 4) Presence of RPE tears, angoid streaks or pathologic myopia. 5) Concomitant conditions/diseases including uncontrolled glaucoma and intraocular inflammation 6) Patients who the doctor in charge judges are ineligible for the study

Design outcomes

Primary

MeasureTime frame
The change of the amplitude of the focal macular ERG at the 12 month from baseline.

Secondary

MeasureTime frame
1. Change of BCVA at the 12 month. 2. Change of the amplitude of the focal macular ERG at the 3,6 and 12 month. 3. Change of the retinal thickness evaluated by SD-OCT at the 12 month. 4. Correlation between the focal macular ERG amplitude and BCVA. 5. Correlation between the focal macular ERG amplitude and retinal thickness.

Countries

Japan

Contacts

Public ContactShigeki Machida

Dokkyo Medical University, Koshigaya Hospital Department of Ophthalmology

machidas@dokkyomed.ac.jp048-965-1111

Outcome results

None listed

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