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

A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225235

Enrollment

640

Registered

2020-06-18

Start date

2020-06-30

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

Diabetic Macular Edema: Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Interventions

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 via

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Change from baseline in BCVA at week 48.	—

Countries

Canada, Czechia, Germany, Hungary, Puerto Rico, United Kingdom, United States

Contacts

Public Contactcontact Dedicated

Bayer Yakuhin, Ltd.

byl_ct_contact@bayer.com+81-6-6133-6363

Outcome results

None listed

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