Unique ID issued by UMIN | UMIN000024588 |
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Receipt number | R000028231 |
Scientific Title | Study to examine the efficacy of modified treat and extend regimen of aflibercept to central retinal vein occlusion with cystoid macular edema |
Date of disclosure of the study information | 2016/10/27 |
Last modified on | 2023/11/02 09:11:34 |
Study to examine the efficacy of modified treat and extend regimen of aflibercept to central retinal vein occlusion with cystoid macular edema
Modified treat and extend regimen of aflibercept to central retinal vein occlusion with cystoid macular edema
Study to examine the efficacy of modified treat and extend regimen of aflibercept to central retinal vein occlusion with cystoid macular edema
Modified treat and extend regimen of aflibercept to central retinal vein occlusion with cystoid macular edema
Japan |
central retinal vein occlusion
Ophthalmology |
Others
NO
To investigate the efficacy of aflibercept with modified treat and extend regimen to visual acuity, number of doses and visits number of times in patients with central retinal vein occlusion with cystoid macular edema.
Efficacy
Visual acuity and central macular thickness at month 12 after initial injection of aflibercept
Visual acuity and central macular thickness at month 24 after initial injection of aflibercept
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Two years of modified treat and extend (2 weeks) of Aflibercept 2 mg
20 | years-old | <= |
89 | years-old | >= |
Male and Female
Patients of central retinal vein occlusion with cystoid macular edema
Onset within 1 year
Hope of treatment
Willingness to provide written informed consent
Target eye: Prior treatment with anti-VEGF drug and steroid drug
Prior treatment with intraocular surgery (<3 months)
Another diseases to decrease visual acuity
Prior treatment with vitrectomy
Fellow eye is already enrolled in the study (If already both eyes onset, the eye which has wider occlusion area is enrolled.)
Prior history of brain cardiovascular evebts
Patient who the doctor in charge judges are ineligible for the study
50
1st name | Hidenori |
Middle name | |
Last name | Takahashi |
Jichi Medical University
Department of Ophthalmology
329-0431
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
0285-58-7382
takahah-tky@umin.ac.jp
1st name | Hidenori |
Middle name | |
Last name | Takahashi |
Jichi Medical University
Department of Ophthalmology
329-0431
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
0285-58-7382
takahah-tky@umin.ac.jp
Jichi Medical University
Bayer Yakuhin Ltd.
Profit organization
Aoki Eye Clinic, Okubo Eye Clinic, Saito Eye Clinic, Takahashi Eye Clinic, JCHO Tokyo Shinjuku Medical Center
Jichi Medical University
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
0285-58-7550
rinri@jichi.ac.jp
NO
自治医科大学附属病院(栃木県)、青木眼科医院(栃木県)、おおくぼ眼科(栃木県)、斎藤眼科医院(栃木県)、たかはし眼科(栃木県)、JCHO東京新宿メディカルセンター(東京都)
2016 | Year | 10 | Month | 27 | Day |
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000028231&t
Unpublished
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000028231&t
50
BCVA and CST showed significant improvement at month 12 (0.19 [0.38] and 271 [105] um, respectively; both P < 0.0001, paired t-test). BCVA and CST also showed significant improvement at 24 months (0.27 [0.45] and 255 [75] um, respectively, P = 0.0004 and P < 0.0001, paired t-test).
2022 | Year | 11 | Month | 14 | Day |
Fifty eyes of 50 patients were enrolled in the study.
Mean patient age was 70 years at the start of treatment.
Mean baseline BCVA (logMAR) was 0.50 and mean baseline CST was 557 um.
There were 14 dropouts (6 declined treatment, 4 were lost to follow-up, 2 underwent cataract surgery, 1 underwent pan-retinal photocoagulation, and 1 had a cerebral infarction).
One serious systemic adverse event occurred in a patient who developed a renal infarction 2 months after IVA and a cerebral infarction 3 months after IVA. The relationship with IVA was unknown.
Main outcome measures were best-corrected visual acuity and central subfield thickness at 12 months. Secondary endpoints were BCVA and CST at 24 months.
Completed
2016 | Year | 10 | Month | 24 | Day |
2016 | Year | 10 | Month | 17 | Day |
2016 | Year | 10 | Month | 27 | Day |
2021 | Year | 09 | Month | 23 | Day |
2022 | Year | 09 | Month | 23 | Day |
2016 | Year | 10 | Month | 27 | Day |
2023 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028231
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