Status:
COMPLETED
Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Diabetic Macular Edema (DME)
Neovascular Age-Related Macular Degeneration (nAMD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your ...
Eligibility Criteria
Inclusion
- Key
- Patient must have diabetic macular edema (DME) or neovascular "wet" age-related macular degeneration (nAMD) in the study eye
- Study eye considered by the retina specialist to be eligible for treatment with 8 mg aflibercept
- Key
Exclusion
- Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past IVT injections with any agent in either eye
- Treatment with any IVT injection in the study eye within the 25 days prior to day 1
- Intraocular pressure (IOP) \>25 mm Hg in the study eye at screening
- Any intraocular surgery in the study eye at any time during the past 3 months
- Any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational, including steroids) in the study eye
- NOTE: Other protocol Defined Inclusion/Exclusion Criteria Apply
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05989126
Start Date
April 15 2024
End Date
May 31 2024
Last Update
May 31 2025
Active Locations (2)
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1
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
2
Retina Consultants of Texas
The Woodlands, Texas, United States, 77385