UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016036
Receipt number R000018185
Scientific Title Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy
Date of disclosure of the study information 2015/01/01
Last modified on 2018/12/04 15:45:50

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy

Acronym

Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy

Scientific Title

Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy

Scientific Title:Acronym

Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy

Region

Japan


Condition

Condition

Diabetic macular edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the usefulness of aflibercept in vitrectomized eyes with recurrent or prolonged diabetic macular edema

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Change of central macular thickness measured by OCT from baseline to month 6

Key secondary outcomes

・Change of best-corrected visual acuity from baseline to month 6
・Proportion of patients with 2-line improvement in best-corrected visual acuity from baseline to month 6
・Proportion of patients with 20% improvement in central macular thickness measured by OCT from baseline to month 6
・Change of retinal sensitivity measured by humphrey (10-2) from baseline to month 6
・Change of subjective symptom by National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25) from baseline to month 6
・Adverse event at moth 6


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

Clinicians should inject aflibercept (EYLEA) 2 mg dosed in the eye monthly for 5 initial months and then inject monthly until 12 months after first administration according to following re-injection criteria.
< re-injection criteria >
Clinicians decide additional injection of aflibercept (EYLEA) 2 mg until under 250um in central macular thickness or below 0 in best-corrected logMAR visual acuity.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Vitrectomized eye with recurrent or prolonged diabetic macular edema more than 6 months after vitrectomy
( more than 300um in central macular thickness measured by OCT retinal map)
2) 0.2-1.2 in best-corrected logMAR visual acuity
3) Type 1 or Type 2 diabetes mellitus
(20 years and older)
4) Vitrectomy was performed for not proliferative diabetic retinopathy but for diabetic macular edema
5) Written informed consent was obtained

Key exclusion criteria

1) Use of any anti VEGF therapy for candidate eyes after vitrectomy
2) Use of any steroid therapy (except for eye drop) for candidate eyes within 3 months prior to initial injection
3) Intraocular,periocular inflammation or infection in candidate eye
4) Allergy history for drug used in this trial
5) Women who are pregnant or breast feeding or who are capable of becoming pregnant
6) Focal, grid laser photocoagulation within 3 months prior to initial injection
7) Proliferative diabetic retinopathy such as vitreous hemorrhage,preretinal hemorrhage,neovascularization, proliferative membrane,tractional retinal detachment
8) Some of optic disc atrophy
9) Cataract that would interfere with required fundus examinations, fundus photographs or OCT
10) Cataract surgery within 6 months prior to initial injection
11) Systematic diseases( sever heart failure, stroke, blood disease, malignant tumor)
12) History of systematic steroids treatment
13) Sever renal failure (serum creatinine>2.0 mg/dL)
14)Presence of uncontrolled hypertension
(systolic>180mmHg,diastolic>110mmHg)
15) HbA1c>10%
16) Considered unsuitable candidate by clinicians

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshida Shigeo

Organization

Kyushu university

Division name

Ophthalmology

Zip code


Address

Fukuoka

TEL

092-642-5648

Email

yosida@med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshida Shigeo

Organization

Kyushu university

Division name

Ophthalmology

Zip code


Address

Fukuoka

TEL

092-642-5648

Homepage URL


Email

yosida@med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu 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


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

九州大学病院


Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 01 Month 19 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 05 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 12 Month 23 Day

Last modified on

2018 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018185


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name