Investigation of TAE Regimen of Aflibercept for CRVO-ME

JRCT ID: jRCTs031180355

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Central retinal vein occlusion with macular edema
• Date of first enrollment: 09/04/2018
• Target sample size: 40
• Study type: Interventional
• Intervention(s): EYLEA (Aflibercept (genetical recombination)) is administered intravitreally 2 mg (0.05 mL) per dose. Dosing interval should be at least 4 weeks and follow the research plan with Treat and Extend Regimen.

Outcome(s)

• Primary Outcome: Average change in best corrected visual acuity (BCVA) at week 24 from baseline.

Secondary Outcome

1. Average change in BCVA from baseline to week 52.
2. Average change of Center Retinal Thickness by Optical Coherence Tomography (OCT) from baseline to week 4, week 24 and week 52.
3. Comparison and change of foveal avascular zone (FAZ), Vascular Density in each levels by OCT Angiography (OCTA) at baseline, week 24 and week 52.
4. Evaluation of avascular field (NPA) by fluorescence angiography (FA) examination at Baseline, week 24 and week 52.
5. Change in retina sensitivity by microperimetry (MP-3) from baseline to week 4, week 24 and week 52.
6. The average number of Aflibercept administration (times per year) until week 52, and the injection interval until week 52 and at week 52.
7. Change in Quality of Vision by NEI-VFQ-25 from Baseline to Week 24 and Week 52.
8. Adverse events, serious adverse events, side effects.

Key inclusion & exclusion criteria

• Age minimum: 20 years old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) 20 years and over
2) Within 9 months from symptoms (onset) of visual acuity decline
3) Decreased visual acuity due to macular edema according to central retinal vein occlusion (decimal visual acuity is 0.7 or less)
4) the consent of this research
5) Central Subfield Retinal thickness > 300 micro meter
6) Possible to have an intention to conduct the inspection scheduled for visit and this research

Exclude criteria

1) Binocular CRVO
2) Glaucoma with poor control (intraocular pressure > 25 mmHg)
3) High blood pressure with poor control
4) Decreased visual acuity due to non-CRVO-ME in the target eye (age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular forebrain, atrophy of the macula)
5) iris neovascularization, vitreous hemorrhage, traction retinal detachment in the target eye
6) Topical steroid administration within the past 180 days for the target eye
7) Anti-VEGF drug within the past 90 days for the target eye Intravitreal injection
8) Cataract surgery history within the past 90 days for the target eye
9) posterior capsule opening operation within the past 30 days for the target eye
10) All intraocular surgical history within the past 90 days for the target eye
11) Pan-retinal photocoagulation in the target eye
12) Intermediate translucers difficult to obtain fundus photographs and OCT images in the target eyes
13) Administration of systemic angiogenesis inhibitor within 180 days from the scheduled initial dose of aflibercept
14) Cerebrovascular disorder and / or myocardial infarction within 180 days from the scheduled initial dose of aflibercept15) Renal failure that may require dialysis or dialysis
16) Systemic diseases requiring the administration of drugs that may affect the results of this study
17) Patients with a history of hypersensitivity to the ingredients of this drug
18) Patients infected with eyes or around the eyes, or patients suspected to be infected
19) Patients with severe inflammation in the eye
20) Pregnant women or women who may be pregnant
21) Women who are breastfeeding
22) Patients who wish to have childbirth or do not want contraception during the research period
23) Fluorescein allergy
24) Participation in another trial within 30 days from the scheduled date of aflibercept's first dose

Related Information

• Primary Sponsor: Murata Toshinori
• Secondary Sponsor: Bayer Yakuhin, Ltd.
• Secondary ID(s): UMIN000031718