Clinical Trial: Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions

Brief Summary:

The purpose of the study is to test the investigational drug Gamunex-C on the growth of blood vessels over the cornea. This study is being conducted by Dr. Balamurali Ambati at the Moran Eye Center at the University of Utah.

The cornea is the clear outer front part of the eye. In corneal neovascularization, blood vessels grow over the cornea. Corneal neovascularization and ocular anterior segment inflammations are sight-threatening conditions. Lipid deposition and edema with subsequent scar formation can compromise corneal clarity irreversibly. Corneal neovascularization is also a well recognized risk factor for corneal graft failure. In its natural state, the cornea is a site of immune privilege well suited to tissue transplantation. Once vascularized, there is direct exposure of corneal antigens to circulating host immune mechanisms greatly increasing the chance of rejection [Collaborative Corneal Transplantation Study].

Melting or inflammation in the anterior chamber, cornea, or ocular surface can cause irreversible scarring or destruction of the optical elements of the eye, which can compromise vision.

Current standard of care for such conditions includes use of topical steroids and sometimes immunosuppressants (e.g., cyclosporine). These do not address a common underlying corneal neovascularization or melting.

This is a Phase 1 clinical trial of subconjunctival IVIg (Gamunex-C) injection for treatment of corneal neovascularization in the setting of corneal transplantation with neovascularization. Candidates for corneal transplantation with corneal neovascularization in one or more quadrants crossing more than 0.5mm over the limbus will be identified for inclusion in our study.


Detailed Summary:
Sponsor: University of Utah

Current Primary Outcome: Ability to regress neovascularization [ Time Frame: at time of transplant ]

Ability of subconjunctival IVIg (Gamunex-C) injection to regress neovascularization and promote graft survival after corneal transplantation, or retard corneal/anterior segment inflammation in patients with progressive/refractory conditions (corneal melts, ocular cicatricial pemphigoid, or refractory anterior uveitis)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ability to regress neovascularization and promote graft survival [ Time Frame: 28 weeks after transplant ]
    ability of subconjunctival IVIg (Gamunex-C) injection to regress neovascularization and promote graft survival after corneal transplantation, or retard corneal/anterior segment inflammation in patients with progressive/refractory conditions (corneal melts, ocular cicatricial pemphigoid, or refractory anterior uveitis)
  • Ability to regress neovascularization and promote graft survival [ Time Frame: 52 weeks after transplant ]
    ability of subconjunctival IVIg (Gamunex-C) injection to regress neovascularization and promote graft survival after corneal transplantation, or retard corneal/anterior segment inflammation in patients with progressive/refractory conditions (corneal melts, ocular cicatricial pemphigoid, or refractory anterior uveitis)
  • Need for immunosuppression [ Time Frame: week 28 ]
    need for immunosuppression at weeks 28 in both treatment groups
  • Need for immunosuppression [ Time Frame: week 52 ]
    need for immunosuppression at week 52 in both treatment groups
  • Effect on corneal infections [ Time Frame: week 28 ]
    Effect on corneal infections or other side effects through week 28 in both treatment groups
  • Effect on corneal infections [ Time Frame: Week 52 ]
    effect on corneal infections or other side effects through week 52 in both treatment groups
  • Visual outcome at week 28 [ Time Frame: Week 28 ]
    visual outcome (by ETDRS chart) at week 28 in both treatment groups
  • Visual outcome at week 52 [ Time Frame: Week 52 ]
    visual outcome (by ETDRS chart) at week 52 in both treatment groups
  • Mean number of injections through week 28 [ Time Frame: week 28 ]
    mean number of injections performed per patient through weeks 28
  • Mean number of injections through week 52 [ Time Frame: week 52 ]
    mean number of injections performed per patient through week 52 in patients receiving subconjunctival IVIg (Gamunex-C) injections
  • Need for rescue treatment in standard of care group [ Time Frame: Week 28 ]
    need for rescue treatment in the standard of care group through week 28
  • Need for rescue treatment in standard of care group [ Time Frame: week 52 ]
    need for rescue treatment in the standard of care group through week 52


Original Secondary Outcome: Same as current

Information By: University of Utah

Dates:
Date Received: January 17, 2014
Date Started: July 2014
Date Completion:
Last Updated: August 3, 2016
Last Verified: August 2016