UMIN-CTR Clinical Trial

Public title

Study of Treat and Extend Regimen using Aflbercept for macular edema (CRVO-ME) associated with central retinal vein occlusion

Acronym

Investigation of TAE Regimen of Aflibercept for CRVO-ME

Scientific Title

Study of Treat and Extend Regimen using Aflbercept for macular edema (CRVO-ME) associated with central retinal vein occlusion

Scientific Title:Acronym

Investigation of TAE Regimen of Aflibercept for CRVO-ME

Region

Japan

Condition

Central retinal vein occlusion with macular edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To reveal the effectiveness and safety of Aflbercept intravitreal injection by Treat and Extend Regimen for patients with macular edema associated with central venous occlusion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

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 24 and 52.
3. Comparison and change of foveal avascular zone (FAZ), Vascular Density in each layers by OCT Angiography (OCTA) at week 24 and 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, 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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

intravitreal Aflibercept injection

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

20 years and over
Within 9 months from symptoms (onset) of visual acuity decline
Decreased visual acuity due to macular edema according to central retinal vein occlusion (decimal visual acuity is 0.7 or less)
the consent of this research

Key exclusion criteria

1) Binocular CRVO
2) Glaucoma with poor control (intraocular pressure > 24 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 Afli Berceptet
14) Cerebrovascular disorder and / or myocardial infarction within 180 days from the scheduled initial dose of Afli Berceptet
15) 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 Afriveltept's first dose

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Toshinori Murata

Organization

Shinshu University

Division name

Dept. Ophthalmology

Zip code

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2664

Email

murata@shinshu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Akira Imai

Organization

Shinshu University

Division name

Dept. Ophthalmology

Zip code

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2664

Homepage URL

Email

imai@shinshu-u.ac.jp

Institute

Shinshu University

Institute

Department

Personal name

Organization

Bayer Yakuhin, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

03

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2018

Year

03

Month

12

Day

Date of IRB

Anticipated trial start date

2018

Year

03

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

03

Month

14

Day

Last modified on

2018

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036226