Status:
TERMINATED
Using Aflibercept Injection to Treat Blood Vessel Growth Over the Cornea
Lead Sponsor:
Balamurali Ambati
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Corneal Neovascularization
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The cornea is the clear front part of the eye. Corneal neovascularization, the excessive growth of blood vessels into the cornea, is a sight-threatening condition. Corneal neovascularization is also a...
Detailed Description
Corneal neovascularization is a sight threatening condition and is also a well recognized risk factor for corneal graft failure. Current standard of care to prevent graft rejection includes use of top...
Eligibility Criteria
Inclusion
- A patient must meet the following criteria to be eligible for inclusion in the study:
- Candidates for corneal transplantation (only one eye per patient would be enrolled)
- Patients with corneal neovascularization in one or more quadrants crossing more than 1.0 mm over the limbus at time of enrollment in the study
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
- Age 18 or over
Exclusion
- A patient who meets any of the following criteria will be excluded from the study:
- Patients receiving antiangiogenic anti-VEGF medication either systemically or intravitreally for other pathology or have received these drugs within 3 months of study enrollment
- Patients with active corneal infection requiring additional treatment modalities
- Patients receiving coumadin with INR \>2.0, other anti-thrombotic agents (e.g., aspirin, Plavix) permitted at discretion of investigator
- History of cerebrovascular accident or myocardial infarction within 6 months prior to study enrollment
- Uncontrolled blood pressure- defined as SBP\>160 mmHg or DBP \>95mmHg while patient is sitting
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01868360
Start Date
June 1 2013
End Date
October 1 2015
Last Update
October 7 2015
Active Locations (1)
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1
John A. Moran Eye Center
Salt Lake City, Utah, United States, 84132