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 |
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Health condition(s) or Problem(s) studied | Diabetic Macular Edema: Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus |
Date of first enrollment | 30/06/2020 |
Target sample size | 640 |
Countries of recruitment | Canada,Czechia,Germany,Hungary,Puerto Rico,United Kingdom,United States |
Study type | Interventional |
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 Outcome | Change from baseline in BCVA at week 48. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
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
Primary Sponsor | Bayer Yakuhin, Ltd. |
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Secondary Sponsor | Regeneron Pharmaceuticals |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04429503,JapicCTI-205331 |
Contact
Public contact | |
Name | contact Dedicated |
Address | 2-4-9 Umeda, Kita-ku, Osaka, Osaka |
Telephone | +81-6-6133-6363 |
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 |
byl_ct_contact@bayer.com | |
Affiliation | Bayer Yakuhin, Ltd. |