Development of Brilliant Blue G (BBG) as a new surgical dye for internal limiting membrane (ILM) staining in vitrectomy.

Development of Brilliant Blue G (BBG) as a new surgical dye for internal limiting membrane (ILM) staining in vitrectomy. - A new vital surgical dye for vitrectomy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1091220148

Enrollment

Registered

2013-11-18

Start date

2014-01-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

macular hole, epiretinal membrane, macular hole retinal detachment cased by high myopia , proliferative vitreoretinopathy, preproliferative diabetic retinopathy, diabetic macular edema, macular edema caused by occlusion of retinal vein.

Interventions

Intervention type:DRUG Name of intervention:A0001 Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRAVITREAL Dose per administration:0.125 0.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients required for vitrectomy in one or both eyes Primary diseases for vitrectomy are macular hole, epiretinal macular membrane, macular hole retinal detachment cased by high myopia , proliferativevitreoretinopathy, preproliferative diabetic retinopathy, diabetic macular edema, macular edema cased by occlusion of retinal vein, and stainig and peeling of internal limiting membrane in vitrectomy are necessary. 2) Age : >=20 years old at the time of obtaining informed consent 3) Male or female passed 2 years after menopause 4) Patients comply with the schedule instructed by PI or SI 5) Patients take part in this trial based on their own free will and give informed consent in written form.

Exclusion criteria

Exclusion criteria: 1) Vitrectomized eye. 2) Has serious of digestive, circulatory, kidney, liver, or blood/coagulation complications 3) Had present and past uveitis or glaucoma 4) Has a history of drug hypersensitivity reactions for Triamcinolone acetonide, mydriatic, antibacterial eyedrops or local anesthetic. 5) Has a history of drug or alcohol abuse 6) Had taken this clinical trial 7) Will take part in in another clinical trial or clinical research during this clinical trial 8) Is deemed unsuitable for this trial by PI or SI

Design outcomes

Primary

Measure	Time frame
Evaluate the degree of visualization by independent data monitoring committee	—

Secondary

Measure	Time frame
Evaluate the degree of visualization by operator	—

Countries

Japan

Contacts

Public ContactMakiko Uchiyama

Kyushu University Hospital

m-uchi@med.kyushu-u.ac.jp+81-92-642-6291

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026