A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Wet Age-related Macular Degeneration (DRAW).



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:July 2014
End Date:July 2017
Contact:Lisa C Greer, MBA
Email:lisa.greer@UNMC.edu
Phone:402-559-1851

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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.

Inclusion Criteria:

1. Age > 50 years

2. Active neovascular AMD, with no history of treatment in the study eye 2.1 10 patients
with non-vitrectomized eyes 2.2 5 patients with vitrectomized eyes

3. Phakic and pseudophakic eyes are allowed in the study.

4. Willing and able to provide written informed consent after the nature of the study
has been explained, and prior to any research-related procedures

5. Willing and able to comply with clinic visits and study-related procedures

Exclusion Criteria:

1. Presence of other retinal vascular diseases (diabetic retinopathy, vein occlusion)
that could affect the VEGF levels within the eye

2. Known hypersensitivity to aflibercept

3. Autoimmune disease of the anterior segment or posterior chamber including chronic
keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye

4. Infectious conjunctivitis, keratitis, or endophthalmitis of either eye

5. Previous participation in any studies of investigational drugs within 1 month
preceding Day 0

6. Any clinically significant acute or chronic medical condition that would preclude
participation in a clinical study

7. Pregnant or breast-feeding women

8. Sexually active men* or women of childbearing potential** who are unwilling to
practice adequate contraception during the study (adequate contraceptive measures
include stable use of oral contraceptives or other prescription pharmaceutical
contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device
(IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam,
or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) *Contraception is
not required for men with documented vasectomy. **Postmenopausal women must be
amenorrheic for at least 12 months in order not to be considered of child bearing
potential. Pregnancy testing and contraception are not required for women with
documented hysterectomy or tubal ligation.
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Omaha, Nebraska 68105
Phone: 402-559-2971
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