Retina Consultants of Southern Colorado | Colorado Springs, CO
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This study is researching an experimental drug called aflibercept 8 mg, referred to as "study drug". The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.
The aim of the study is to see how safe and effective aflibercept 8 mg injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria for Participants with nAMD:
≥50 years of age
Choroidal neovascularization (CNV) lesions secondary to nAMD, requiring anti-VEGF treatment per investigator.
Key Inclusion Criteria for Participants with DME:
≥18 years of age
DME with central involvement (in the central subfield on Spectral domain optical coherence tomography [SD-OCT]) in the study eye as determined by the investigator
Key Inclusion for All Participants:
Previously treated with ≥3 anti-VEGF IVT injections in the 5 months (~150 days) prior to visit 1
Key Exclusion Criteria for Participants with nAMD:
Evidence of CNV due to any cause other than nAMD in either eye
Key Exclusion Criteria for Participants with DME:
Evidence of macular edema due to any other cause other than diabetes mellitus
Active proliferative DR in the study eye
NOTE: Other protocol defined inclusion / exclusion criteria apply.
Primary purpose
Allocation
Interventional model
Masking
400 participants in 1 patient group
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Central trial contact
Clinical Trials Administrator
Data sourced from clinicaltrials.gov
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