A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema

Launched by BAYER · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for diabetic macular edema (DME), an eye condition caused by diabetes that leads to swelling in the retina and vision problems. Researchers want to find out how well an 8 milligram dose of aflibercept works compared to a lower 2 milligram dose. Aflibercept is an injection that helps prevent fluid from leaking in the eye, which can improve vision. The trial will involve Chinese participants who are at least 18 years old and have specific vision requirements due to DME.

Participants in the study will receive either the higher or lower dose of aflibercept over about 63 weeks, with regular visits for treatment and eye exams to monitor their vision and overall eye health. This research aims to see if the higher dose, given less frequently, can provide similar benefits while making treatment easier for patients. It's important to note that this study is currently recruiting participants, and after the study ends, those involved can switch to other approved treatments for DME if needed.

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Eligibility criteria

• Key Inclusion Criteria:
• • Men or women ≥18 years of age
• • Chinese participants with type 1 or type 2 diabetes mellitus and diabetic macular edema (DME) with central involvement defined as CST ≥300 µm (or ≥320 µm on Heidelberg Spectralis) in the study eye as determined by the reading center at the screening visit and confirmed by the site at baseline visit
• • 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 at the screening and baseline visits with decreased vision determined to be primarily the result of DME
• • Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention.
• Key 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
• • Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in the study eye within 12 weeks (84 days) of the screening visit
• • IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, conbercept, faricimab, brolucizumab, pegaptanib sodium) in the study eye within 12 weeks (84 days) of the screening visit
• • Previous use of topical steroids within 4 weeks (28 days) of the screening visit or of intraocular or periocular corticosteroids in the study eye within 16 weeks (112 days) of the screening visit, or ILUVIEN or OZURDEX IVT implants at any time
• • Prior ocular investigational agents (that have not been approved) in either eye (e.g., IVT, suprachoroidal injections, ocular implants, etc.) at any time.
• • Previous treatment with an investigational or approved intraocular gene therapy or cell therapy in either eye at any time.