UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024588
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

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Basic information

Public title

Study to examine the efficacy of modified treat and extend regimen of aflibercept to central retinal vein occlusion with cystoid macular edema

Acronym

Modified treat and extend regimen of aflibercept to central retinal vein occlusion with cystoid macular edema

Scientific Title

Study to examine the efficacy of modified treat and extend regimen of aflibercept to central retinal vein occlusion with cystoid macular edema

Scientific Title:Acronym

Modified treat and extend regimen of aflibercept to central retinal vein occlusion with cystoid macular edema

Region

Japan


Condition

Condition

central retinal vein occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual acuity and central macular thickness at month 12 after initial injection of aflibercept

Key secondary outcomes

Visual acuity and central macular thickness at month 24 after initial injection of aflibercept


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Two years of modified treat and extend (2 weeks) of Aflibercept 2 mg

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

89 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients of central retinal vein occlusion with cystoid macular edema
Onset within 1 year
Hope of treatment
Willingness to provide written informed consent

Key exclusion criteria

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

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hidenori
Middle name
Last name Takahashi

Organization

Jichi Medical University

Division name

Department of Ophthalmology

Zip code

329-0431

Address

3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498

TEL

0285-58-7382

Email

takahah-tky@umin.ac.jp


Public contact

Name of contact person

1st name Hidenori
Middle name
Last name Takahashi

Organization

Jichi Medical University

Division name

Department of Ophthalmology

Zip code

329-0431

Address

3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498

TEL

0285-58-7382

Homepage URL


Email

takahah-tky@umin.ac.jp


Sponsor or person

Institute

Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Bayer Yakuhin Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Aoki Eye Clinic, Okubo Eye Clinic, Saito Eye Clinic, Takahashi Eye Clinic, JCHO Tokyo Shinjuku Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Jichi Medical University

Address

3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan

Tel

0285-58-7550

Email

rinri@jichi.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

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)


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 27 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000028231&t

Publication of results

Unpublished


Result

URL related to results and publications

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000028231&t

Number of participants that the trial has enrolled

50

Results

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).

Results date posted

2022 Year 11 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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.

Participant flow

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).

Adverse events

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.

Outcome measures

Main outcome measures were best-corrected visual acuity and central subfield thickness at 12 months. Secondary endpoints were BCVA and CST at 24 months.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 10 Month 24 Day

Date of IRB

2016 Year 10 Month 17 Day

Anticipated trial start date

2016 Year 10 Month 27 Day

Last follow-up date

2021 Year 09 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2022 Year 09 Month 23 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 27 Day

Last modified on

2023 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028231


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name