UMIN-CTR Clinical Trial

Public title

Evaluation of collateral vessels on optical coherence tomography angiography in macular edema associated with branch retinal vein occlusion (BRVO)

Acronym

Evaluation of collateral vessels on OCTA in macular edema associated with BRVO

Scientific Title

Evaluation of collateral vessels on optical coherence tomography angiography in macular edema associated with branch retinal vein occlusion (BRVO)

Scientific Title:Acronym

Evaluation of collateral vessels on OCTA in macular edema associated with BRVO

Region

Japan

Condition

Branch Retinal Vein Occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate collateral vessels using optical coherence tomography angiography in eyes with macular edema secondary to branch retinal vein occlusion.

Basic objectives2

Others

Basic objectives -Others

Confirmatory

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

The time, the frequency, and the location of occurrence on collateral vessels

Key secondary outcomes

Whether the collateral vessels were leaky, whether the collateral vessels were accompanied by microaneurysms, and the relationship with macular edema

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.BRVO patients with macular edema who underwent optical coherence tomography angiography at baseline and were followed-up more than 6 months
2.Japanese patients
3.Patients considered as eligible for this study by the investigator

Key exclusion criteria

1.Patients whose images were too poor quality to be analyzed, who had thick retinal hemorrhage, or severe macular edema
2.Presence of other macular disease
3.High myopia greater than -6.0 diopters(D)
4.Patients judged by the investigator to be ineligible for other reasons

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yoshio Hirano

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Depertment of Ophthalmology and Visual Science

Zip code

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 4678601, Japan

TEL

052-853-8251

Email

yoshio.hirano@gmail.com

Name of contact person

1st name
Middle name
Last name	Yoshio Hirano

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Depertment of Ophthalmology and Visual Science

Zip code

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 4678601, Japan

TEL

052-853-8251

Homepage URL

Email

yoshio.hirano@gmail.com

Institute

Depertment of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name

Organization

Depertment of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

other

Name of secondary funder(s)

Depertment of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences

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

10

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Collateral vessels around the macula were detected in 25 out of 30 eyes and were already formed at the initial visit. The macular edema was resolved in 16 out of 25 eyes with collateral vessels and 2 out of 5 eyes without collateral vessels, respectively. The mean duration of macular edema resolution was 13 months with collateral vessels and 15 months without collateral vessels, respectively, which was not significantly difference. Eight eyes of 22 eyes who underwent fluorescein angiography had leaky collateral vessels and microaneurysms were detected in all the eyes, whereas the other 14 eyes had nonleaky collateral vessels and microaneurysms were detected in 7 eyes.

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

Completed

Date of protocol fixation

2018

Year

03

Month

01

Day

Date of IRB

Anticipated trial start date

2018

Year

03

Month

31

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We reported that OCTA can visualize collateral vessels in macular edema associated with BRVO (Suzuki N et al. AJO 2016).

Registered date

2018

Year

08

Month

23

Day

Last modified on

2018

Year

08

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038556