The change of retinal sensitivity with intravitreal injection of aflibercept for wet type of age-related macular degeneration.

UMIN ID: UMIN000015810

Registered date:01/01/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: wet type age-related macular degeneration
• Date of first enrollment: 2016/10/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The change amount of retinal sensitivity at six month from base line after initial therapy of intravitreal injection of aflibercept for wet type of age-related macular degeneration
• Secondary Outcome: 1.The ratio of patients with improvement or preservation of visual acuity after intravitreal injection of aflibercept 2.The change amount of visual aquity at 1,3,6,12 months from base line 3.The change amount of central foveal thickness at 1,3,6,12 months from base line 4.The ratio of patients with subretinal or intraretinal exdative change at 6 and 12 months 5.The change amount of retinal sensitivity at 1,3 and 12 months from base line

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Patients who need to undergo intravitreal injection of aflibercept for their both eyes. 2.The lesion is more than 12 disc diameter area with fluorecein angiography 3.Subretinal hemorrhage with 50 percent or more of the lesion area 4.Subretinal scar or fibrosis with 50 percent or more of the lesion area 5.retinal pigment epithelium tear 6.patients who had past stage 3 or 4 macular hole 7.patients who received the therapy with triamcinolone acetonide within 6 months 8.patients who received the therapy with Dexamethasone within 30 days 9.patients who received intra occular surgery within 6 months 10.patients who received pars plana vitrectomy or submacular surgery 11.patinets with intra or external occular infection or inflamation 12.patients with uveitis in any eye 13.fluorescein or indocianine green alergy 14.pregnancy or possibility of pregnancy or woman who are lactating 15.patient who are judged unsuitable for the investigation by the doctor

Related Information

• Primary Sponsor: Department of Ophthalmology and Visual Science Chiba University Graduate School of Medicine
• Source(s) of Monetary Support: Department of Ophthalmology and Visual Science Chiba University Graduate School of Medicine