Neovascular Macular Degeneration Clinical Trial
Official title:
A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Wet Age-related Macular Degeneration (the DRAW Study)
The main goal is to study way that aflibercept injection behaves in the eye and in the body of patients with wet macular degeneration, in patients who have had previous vitreous removal surgery.
A pharmacokinetic study of intravitreal Aflibercept injection vitrectomized and non-vitrectomized eyes with Wet age-related macular degeneration (the DRAW study). The primary objective is to investigate and characterize the intraocular pharmacokinetics of intravitreal aflibercept injection in vitrectomized and non-vitrectomized eyes with neovascular Age-related Macular Degeneration (AMD). The secondary objective is to assess the systemic pharmacokinetics of intravitreal aflibercept injection. Little information is known about the intraocular pharmacokinetics of intravitreal aflibercept injection in human eyes. In addition, the durability of intravitreal aflibercept injection in vitrectomized eyes is not known, since individuals with a history of vitrectomy have been excluded from clinical trials in neovascular AMD. There have also been no studies on systemic levels following intravitreal aflibercept injection, which would have implications for normal vascular hemostasis and wound repair in which vascular endothelial growth factor (VEGF) plays an important role. The proposed research will fill in these gaps in the knowledge base for intravitreal aflibercept injection. Two arms (non-vitrectomized, and vitrectomized) are included in the study to evaluate the intraocular and systemic pharmacokinetics of intravitreal aflibercept injection The study involves neovascular AMD patients divided into two groups: 5 patients with history of vitrectomy and 10 patients with no history of vitrectomy. Plasma blood and aqueous fluid will be collected at baseline, then 2mg of intravitreal aflibercept injection administered at time 0 (day 0). At 4 hours post injection, plasma (blood) and aqueous fluid will be collected again, as well as on days 1, 3, 7,14, and 28. Intravitreal aflibercept injection levels in the samples will be assessed and compared among the two groups. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00590694 -
Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
|
Phase 2/Phase 3 | |
| Completed |
NCT02120950 -
Aflibercept in Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
| Completed |
NCT01245387 -
Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration
|
N/A |