Back to resultsPharmacokinetic Study of Intravitreal Aflibercept Injection in Eyes With Wet Age-related Macular Degeneration (DRAW)
Primary Purpose
Neovascular Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aflibercept
Sponsored by
About this trial
This is an interventional other trial for Neovascular Macular Degeneration focused on measuring AMD, Neovascularization, macular degeneration, wet macular degeneration, vitrectomy
Eligibility Criteria
Inclusion Criteria:
- Age > 50 years
- 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
- Phakic and pseudophakic eyes are allowed in the study.
- Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures
- Willing and able to comply with clinic visits and study-related procedures
Exclusion Criteria:
- Presence of other retinal vascular diseases (diabetic retinopathy, vein occlusion) that could affect the VEGF levels within the eye
- Known hypersensitivity to aflibercept
- Autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye
- Infectious conjunctivitis, keratitis, or endophthalmitis of either eye
- Previous participation in any studies of investigational drugs within 1 month preceding Day 0
- Any clinically significant acute or chronic medical condition that would preclude participation in a clinical study
- Pregnant or breast-feeding women
- 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.
Sites / Locations
- University of Nebraska Medical Center, Truhlsen Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Aflibercept
Aflibercept in Non-Vitrectomized eyes
Arm Description
Subjects who have had a vitrectomy previously
Patients who have not had vitrectomy.
Outcomes
Primary Outcome Measures
Pharmacokinetic (PK) aflibercept aqueous
The primary endpoint in the study consists of intraocular aflibercept (free and bound) concentrations following intravitreal aflibercept injection.
Secondary Outcome Measures
PK Aflibercept plasma
The secondary endpoints are plasma concentrations of aflibercept (free and bound) following intravitreal aflibercept injection.
Full Information
NCT ID
NCT02204683
First Posted
July 28, 2014
Last Updated
September 1, 2023
Sponsor
University of Nebraska
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02204683
Brief Title
Pharmacokinetic Study of Intravitreal Aflibercept Injection in Eyes With Wet Age-related Macular Degeneration
Acronym
DRAW
Official Title
A Pharmacokinetic Study of Intravitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Wet Age-related Macular Degeneration (the DRAW Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2014 (Actual)
Primary Completion Date
December 14, 2016 (Actual)
Study Completion Date
December 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Macular Degeneration
Keywords
AMD, Neovascularization, macular degeneration, wet macular degeneration, vitrectomy
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aflibercept
Arm Type
Other
Arm Description
Subjects who have had a vitrectomy previously
Arm Title
Aflibercept in Non-Vitrectomized eyes
Arm Type
Other
Arm Description
Patients who have not had vitrectomy.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Intravitreal aflibercept
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) aflibercept aqueous
Description
The primary endpoint in the study consists of intraocular aflibercept (free and bound) concentrations following intravitreal aflibercept injection.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
PK Aflibercept plasma
Description
The secondary endpoints are plasma concentrations of aflibercept (free and bound) following intravitreal aflibercept injection.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 50 years
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
Phakic and pseudophakic eyes are allowed in the study.
Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures
Willing and able to comply with clinic visits and study-related procedures
Exclusion Criteria:
Presence of other retinal vascular diseases (diabetic retinopathy, vein occlusion) that could affect the VEGF levels within the eye
Known hypersensitivity to aflibercept
Autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye
Infectious conjunctivitis, keratitis, or endophthalmitis of either eye
Previous participation in any studies of investigational drugs within 1 month preceding Day 0
Any clinically significant acute or chronic medical condition that would preclude participation in a clinical study
Pregnant or breast-feeding women
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana V Do, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center, Truhlsen Eye Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study of Intravitreal Aflibercept Injection in Eyes With Wet Age-related Macular Degeneration
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