Investigation of TAE Regimen of Aflibercept for CRVO-ME
- Conditions
- Central retinal vein occlusion with macular edema
- Registration Number
- JPRN-jRCTs031180355
- Lead Sponsor
- Murata Toshinori
- Brief Summary
The current study was discontinued because it was judged that it would be extremely difficult to reach the planned number of patients due to the difficulty in incorporating subjects. And then, it is difficult to draw any meaningful conclusions because there were 7 cases conducted compared to the planned number of 30 cases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 7
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average change in best corrected visual acuity (BCVA) at week 24 from baseline.
- Secondary Outcome Measures
Name Time Method 1. Average change in BCVA from baseline to week 52. <br>2. Average change of Center Retinal Thickness by Optical Coherence Tomography (OCT) from baseline to week 4, week 24 and week 52. <br>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. <br>4. Evaluation of avascular field (NPA) by fluorescence angiography (FA) examination at Baseline, week 24 and week 52. <br>5. Change in retina sensitivity by microperimetry (MP-3) from baseline to week 4, week 24 and week 52. <br>6. The average number of Aflibercept administration (times per year) until week 52, and the injection interval until week 52 and at week 52. <br>7. Change in Quality of Vision by NEI-VFQ-25 from Baseline to Week 24 and Week 52.<br>8. Adverse events, serious adverse events, side effects.