Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 11 of 260 for:    macular degeneration | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of Nebraska
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Diana V. Do, University of Nebraska
ClinicalTrials.gov Identifier:
NCT02204683
First received: July 28, 2014
Last updated: August 26, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Neovascular Macular Degeneration
Drug: Aflibercept
Phase 1

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • PK Aflibercept plasma [ Time Frame: 28 days ]
    The secondary endpoints are plasma concentrations of aflibercept (free and bound) following intravitreal aflibercept injection.


Estimated Enrollment: 15
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)
Arms Assigned Interventions
Aflibercept
Subjects who have had a vitrectomy previously
Drug: Aflibercept
Intravitreal aflibercept
Other Name: Eylea
Aflibercept in Non-Vitrectomized eyes
Patients who have not had vitrectomy.
Drug: Aflibercept
Intravitreal aflibercept
Other Name: Eylea

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.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02204683

Contacts
Contact: Lisa C Greer, MBA 402-559-1851 lisa.greer@UNMC.edu
Contact: Kristi Miller 402-559-1853 kristi.miller@unmc.edu

Locations
United States, Nebraska
UNMC Truhlsen Eye Institute Recruiting
Omaha, Nebraska, United States, 68105
Contact: Diana v Do, MD    402-559-2971    diana.do@unmc.edu   
Sub-Investigator: Quan D Nguyen, MD, MSc         
Sub-Investigator: Loren s Jack, MD         
Sponsors and Collaborators
University of Nebraska
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Diana V Do, MD University of Nebraska
  More Information

Responsible Party: Diana V. Do, Diana Do, MD, University of Nebraska
ClinicalTrials.gov Identifier: NCT02204683     History of Changes
Other Study ID Numbers: 334-14-FB
Study First Received: July 28, 2014
Last Updated: August 26, 2016

Keywords provided by University of Nebraska:
AMD
Neovascularization
macular degeneration
wet macular degeneration
vitrectomy

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 21, 2017