Aflibercept for corneal neovascularization

Overview

Status: Enrolling by invitation
Keywords: Corneal transplant , Neovascularization
IRB Number: 00065110
Specialty: Ophthalmology
Sub Specialties: Cornea

Brief Summary

The primary objective of the study is to investigate and assess safety of subconjunctival aflibercept injection in patients with corneal neovascularization undergoing corneal transplantation.

The secondary objectives of the study are

  • Assess ability of subconjunctival aflibercept injection to regress neovascularization (at time of transplant, 28 and 52 weeks after transplant) and promote graft survival after corneal transplantation
  • Assess need for immunosuppression at weeks 28 and 52 in both treatment groups
  • Assess effect on corneal infections or other side effects through weeks 28 and 52 in both treatment groups
  • Assess visual outcome (by ETDRS chart) at weeks 28 and 52 in both treatment groups
  • Ascertain mean number of injections performed per patient through weeks 28 and 52 in patients receiving subconjunctival aflibercept injections
  • Evaluate need for rescue treatment in the standard of care group through weeks 28 and 52

Principal Investigator: Balamurali Ambati
Department: Neurobiology And Anatomy
Co Investigator:

Contact Information

Name:Balamurali Ambati
Phone: 801 581 3023
Email: bala.ambati@utah.edu

Inclusion Criteria

A patient must meet the following criteria to be eligible for inclusion in the study:

  1. Candidates for corneal transplantation (only one eye per patient would be enrolled)
  2. 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
  3. Willing and able to comply with clinic visits and study-related procedures
  4. Provide signed informed consent
  5. Age 18 or over

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:

  1. Patients receiving antiangiogenic anti-VEGF medication either systemically or intravitreally for other pathology or have received these drugs within 3 months of study enrollment
  2. Patients with active corneal infection requiring additional treatment modalities
  3. Patients receiving coumadin with INR >2.0, other anti-thrombotic agents (e.g., aspirin, Plavix) permitted at discretion of investigator
  4. History of CVA or MI within 6 months prior to study enrollment
  5. Uncontrolled BP- defined as SBP>160 mmHg or DBP >95mmHg while patient is sitting
  6. Pregnant or breast-feeding women
  7. 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.