A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Wet Age-related Macular Degeneration (DRAW). (DRAW)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Wet Age-related Macular Degeneration (the DRAW Study)|
- Pharmacokinetic (PK) aflibercept aqueous [ Time Frame: 28 days ]The primary endpoint in the study consists of intraocular aflibercept (free and bound) concentrations following intravitreal aflibercept injection.
- PK Aflibercept plasma [ Time Frame: 28 days ]The secondary endpoints are plasma concentrations of aflibercept (free and bound) following intravitreal aflibercept injection.
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Subjects who have had a vitrectomy previously
Other Name: Eylea
Aflibercept in Non-Vitrectomized eyes
Patients who have not had vitrectomy.
Other Name: Eylea
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02204683
|Contact: Lisa C Greer, MBA||402-559-1851||lisa.greer@UNMC.edu|
|Contact: Kristi Millerfirstname.lastname@example.org|
|United States, Nebraska|
|UNMC Truhlsen Eye Institute||Recruiting|
|Omaha, Nebraska, United States, 68105|
|Contact: Diana v Do, MD 402-559-2971 email@example.com|
|Sub-Investigator: Quan D Nguyen, MD, MSc|
|Sub-Investigator: Loren s Jack, MD|
|Principal Investigator:||Diana V Do, MD||University of Nebraska|