NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080225235

Registered date:18/06/2020

Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease (PHOTON)

Basic Information

Recruitment status completed
Health condition(s) or Problem(s) studiedDiabetic Macular Edema: Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus
Date of first enrollment30/06/2020
Target sample size640
Countries of recruitmentCanada,Czechia,Germany,Hungary,Puerto Rico,United Kingdom,United States
Study typeInterventional
Intervention(s)Drug: aflibercept (EYLEA, BAY86-5321)_Intravitreally (IVT) administered as a liquid formulation in a vial Drug: High-dose aflibercept_Intravitreally (IVT) administered as a liquid formulation in a vial

Outcome(s)

Primary OutcomeChange from baseline in BCVA at week 48.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria- Diabetic macular edema (DME) with central involvement in the study eye - Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME - Willing and able to comply with clinic visits and study-related procedures - Provide informed consent signed by study participant or legally acceptable representative Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.
Exclude criteria- Evidence of macular edema due to any cause other than diabetes mellitus in either eye - Active proliferative diabetic retinopathy in the study eye - IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye - Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time - Treatment with ocriplasmin (JETREA) in the study eye at any time

Related Information

Contact

Public contact
Name contact Dedicated
Address 2-4-9 Umeda, Kita-ku, Osaka, Osaka
Telephone +81-6-6133-6363
E-mail byl_ct_contact@bayer.com
Affiliation Bayer Yakuhin, Ltd.
Scientific contact
Name Myoishi Masafumi
Address 2-4-9 Umeda, Kita-ku, Osaka, Osaka
Telephone +81-6-6133-6363
E-mail byl_ct_contact@bayer.com
Affiliation Bayer Yakuhin, Ltd.