NCT02204683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 5, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2016

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

July 28, 2014

Last Update Submit

September 1, 2023

Conditions

Neovascular Macular Degeneration

Keywords

AMDNeovascularizationmacular degenerationwet macular degenerationvitrectomy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic (PK) aflibercept aqueous

    The primary endpoint in the study consists of intraocular aflibercept (free and bound) concentrations following intravitreal aflibercept injection.

    28 days

Secondary Outcomes (1)

  • PK Aflibercept plasma

    28 days

Study Arms (2)

Aflibercept

OTHER

Subjects who have had a vitrectomy previously

Drug: Aflibercept

Aflibercept in Non-Vitrectomized eyes

OTHER

Patients who have not had vitrectomy.

Drug: Aflibercept

Interventions

AfliberceptDRUG

Intravitreal aflibercept

Also known as: Eylea
AfliberceptAflibercept in Non-Vitrectomized eyes

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, Truhlsen Eye Institute

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Neovascularization, PathologicMacular DegenerationWet Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

MetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Diana V Do, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 30, 2014

Study Start

September 5, 2014

Primary Completion

December 14, 2016

Study Completion

December 14, 2016

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations

US(1)