Status:
COMPLETED
A Study to Learn About the Blood Levels of Aflibercept When High-dose Aflibercept is Injected in Both Eyes of Participants With Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
Lead Sponsor:
Bayer
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Diabetic Macular Edema
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Researchers are looking for a better way to treat participants who have diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD). DME is a diabetes-related eye disorder. In...
Eligibility Criteria
Inclusion
- Men or women ≥18 years of age (or country's legal age of adulthood if the legal age is \>18 years).
- Participants (treatment naïve or previously treated) requiring intravitreal anti-vascular endothelial growth factor (VEGF) treatment in both eyes in the opinion of the investigator.
- Participants with type 1 or type 2 diabetes mellitus and DME in both eyes with active central involvement (CI-DME) in at least one eye with central retinal thickness (CRT) ≥300 µm (or ≥320 µm on Spectralis) as determined by the investigator at the screening visit, OR diagnosis of nAMD in both eyes with active subfoveal choroidal neovascularization (CNV) in at least one eye with intraretinal fluid (IRF) and/or subretinal fluid (SRF) on OCT as determined by the investigator at the screening 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 the result of DME or nAMD.
- A female participant is eligible to participate if she is not pregnant or breastfeeding. 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.
Exclusion
- Evidence of macular edema due to any cause other than diabetes mellitus in patients with DME or neovascular age-related macular degeneration in patients with nAMD in either eye.
- Active proliferative diabetic retinopathy (DR) in either eye.
- Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in either eye 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 eye within 12 weeks (84 days) of the screening visit or with IVT 8 mg or HD aflibercept in 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 16 weeks (112 days) of the screening visit, or OZURDEX® implant within 180 days of the screening visit or ILUVIEN® or RETISERT® implant at any time
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06591598
Start Date
September 2 2024
End Date
October 14 2025
Last Update
November 3 2025
Active Locations (6)
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1
Fakultní nemocnice Královské Vinohrady - Urologická klinikay
Prague, Czechia, 10034
2
Axon Clinical, s.r.o.
Prague, Czechia, 150 00
3
Budapest Retina Associates
Budapest, Hungary, 1133
4
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032