Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | December 19, 2018 |
| End Date: | February 13, 2019 |
A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
The primary objective of the study is to determine if the pre-filled syringe (PFS) supports
successful preparation and accurate administration of an aflibercept injection.
The secondary objective of the study is to assess ocular safety in the study eye.
successful preparation and accurate administration of an aflibercept injection.
The secondary objective of the study is to assess ocular safety in the study eye.
Key Inclusion Criteria:
- Participants who have neovascular age-related macular degeneration (AMD), diabetic
macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with
diabetic macular edema (DME) in the study eye
Key Exclusion Criteria:
- Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in
either eye
- Any active intraocular inflammation or infection in either eye or history of
intraocular inflammation or infection after past intravitreal injection treatment
(IVT) injections with any agent in either eye
- History of or any current indication of excessive bleeding and recurrent hemorrhages,
including any prior excessive intraocular (including subconjunctival) bleeding or
hemorrhages after IVT injection or intraocular procedures in either eye
- Any intraocular surgery in the study eye at any time during the past 3 months
- Current systemic infectious disease or a therapy for active infectious disease
- Pregnant or breastfeeding women
Note: Other inclusion/ exclusion apply
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