Phase
Condition
Macular Edema
Macular Degeneration
Diabetic Macular Edema
Treatment
Aflibercept (BAY86-5321, Eylea)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men or women ≥18 years of age (or country's legal age of adulthood if the legal ageis >18 years).
Participants (treatment naïve or previously treated) requiring intravitrealanti-vascular endothelial growth factor (VEGF) treatment in both eyes in the opinionof the investigator.
Participants with type 1 or type 2 diabetes mellitus and DME in both eyes withactive central involvement (CI-DME) in at least one eye with central retinalthickness (CRT) ≥300 µm (or ≥320 µm on Spectralis) as determined by the investigatorat the screening visit, OR diagnosis of nAMD in both eyes with active subfovealchoroidal neovascularization (CNV) in at least one eye with intraretinal fluid (IRF)and/or subretinal fluid (SRF) on OCT as determined by the investigator at thescreening visit.
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 eyes with active disease and decreased vision determined to be primarily theresult of DME or nAMD.
A female participant is eligible to participate if she is not pregnant orbreastfeeding. Women of childbearing potential (WOCBP) or men who are sexuallyactive with partners of childbearing potential must agree to use highly effectivecontraception prior to the initial dose/start of the first treatment, during thestudy, and for at least 4 months after the last administration of studyintervention.
Exclusion
Exclusion Criteria:
Evidence of macular edema due to any cause other than diabetes mellitus in patientswith DME or neovascular age-related macular degeneration in patients with nAMD ineither eye.
Active proliferative diabetic retinopathy (DR) in either eye.
Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in eithereye with CI-DME or active nAMD within 12 weeks (84 days) of the screening visit.
Prior treatment with intravitreal (IVT) 2 mg aflibercept (EYLEA) in either eyewithin 12 weeks (84 days) of the screening visit or with IVT 8 mg or HD afliberceptin either eye within 24 weeks (168 days) of the screening visit.
Prior treatment with any other approved IVT agent with anti-VEGF effect (e.g.ranibizumab, bevacizumab, brolucizumab, faricimab, pegaptanib sodium or biosimilars)in either eye within 4 weeks (28 days) of the screening visit.
Prior treatment with any ocular gene or cell therapy treatment in either eye.
Previous use of intraocular or periocular corticosteroids in either eye within 16weeks (112 days) of the screening visit, or OZURDEX® implant within 180 days of thescreening visit or ILUVIEN® or RETISERT® implant at any time
Study Design
Connect with a study center
FN Kralovske Vinohrady
Praha 10, 100 34
CzechiaSite Not Available
Fakultní nemocnice Královské Vinohrady - Urologická klinikay
Praha 10, 10034
CzechiaSite Not Available
AXON Clinical s.r.o.
Praha 5, 150 00
CzechiaActive - Recruiting
Axon Clinical s.r.o
Praha 5, 150 00
CzechiaSite Not Available
Axon Clinical, s.r.o.
Praha 5, 150 00
CzechiaSite Not Available
Bajcsy-Zsilinszky Hospital
Budapest, 1106
HungarySite Not Available
Budapest Retina Associates
Budapest, 1133
HungarySite Not Available
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106
HungarySite Not Available
Semmelweis Egyetem
Budapest, 1122
HungarySite Not Available
Debreceni Egyetem Klinikai
Debrecen, 4032
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
University Hospital Bratislava
Bratislava, 851 07
SlovakiaSite Not Available
Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda
Bratislava, 851 07
SlovakiaSite Not Available
FN nemocnica poliklinikou
Zilina, 012 07
SlovakiaSite Not Available
Fakultna nemocnica s poliklinikou Zilina
Zilina, 012 07
SlovakiaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.