NCT05989126CompletedPhase 3
Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
A Study in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration to Evaluate a High Dose Aflibercept (8 mg) Prefilled Syringe
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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 study eye. A PFS offers a sterile, single dose of study drug within the syringe; this eliminates the need for the retina specialist to prepare the injection syringe from a separate vial. This Phase IIIb study is focused on patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD). The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful preparation and administration of 8 mg aflibercept by retina specialists. The study will also assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the study to better understand if the PFS can be used safely and effectively by retina specialists to administer 8 mg aflibercept.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 3 Aug 2023
- Start date
- 15 Apr 2024
- Primary completion date
- 31 May 2024
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT05989126
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 35
- From 15 Apr 2024 to the primary completion date, 31 May 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any IVT injection in the study eye within the 25 days prior to day 1
- 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
Other illness
- 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
Other
- Intraocular pressure (IOP) \>25 mm Hg in the study eye at screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.