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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Balamurali Ambati, University of Utah
ClinicalTrials.gov Identifier:
NCT02042027
First received: January 17, 2014
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Corneal Neovascularization
Corneal Graft Failure
Anterior Segment Inflammation
Drug: Gamunex-C
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Ability to regress neovascularization [ Time Frame: at time of transplant ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Ability to regress neovascularization and promote graft survival [ Time Frame: 28 weeks after transplant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    need for immunosuppression at weeks 28 in both treatment groups

  • Need for immunosuppression [ Time Frame: week 52 ] [ Designated as safety issue: No ]
    need for immunosuppression at week 52 in both treatment groups

  • Effect on corneal infections [ Time Frame: week 28 ] [ Designated as safety issue: No ]
    Effect on corneal infections or other side effects through week 28 in both treatment groups

  • Effect on corneal infections [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    effect on corneal infections or other side effects through week 52 in both treatment groups

  • Visual outcome at week 28 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
    visual outcome (by ETDRS chart) at week 28 in both treatment groups

  • Visual outcome at week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    visual outcome (by ETDRS chart) at week 52 in both treatment groups

  • Mean number of injections through week 28 [ Time Frame: week 28 ] [ Designated as safety issue: No ]
    mean number of injections performed per patient through weeks 28

  • Mean number of injections through week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    need for rescue treatment in the standard of care group through week 52


Estimated Enrollment: 16
Study Start Date: July 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Gamunex-C 50 mg subconjunctival injections, in addition to standard of care treatment (steroids and cyclosporine). One dose of Gamunex-C injection delivered four weeks prior to corneal transplant surgery and one dose at the time of corneal transplantation. Dose to be repeated if recurrence of corneal neovascularization
Drug: Gamunex-C
Patients will receive 50 mg (0.5 mL) subconjunctival Gamunex-C injection in addition to standard of care treatment (steroids and cyclosporine)
Other Name: IVIg
Active Comparator: Group B
Gamunex-C 50 mg subconjunctival injections, one dose injected for patients with active disease from corneal melts (peripheral ulcerative keratitis; Mooren's ulcer), ocular cicatricial pemphigoid, or anterior uveitis refractory to conventional therapy.
Drug: Gamunex-C
Patients will receive 50 mg (0.5 mL) subconjunctival Gamunex-C injection in addition to standard of care treatment (steroids and cyclosporine)
Other Name: IVIg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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. Patients with refractory anterior uveitis, non-responding corneal melts, or non-responding ocular cicatricial pemphigoid
  4. Willing and able to comply with clinic visits and study-related procedures
  5. Provide signed informed consent
  6. Age 18 or over

Exclusion Criteria:

  1. Patients receiving antiangiogenic anti-VEGF medication either systemically or intravitreally for other pathology or who 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.
  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: NCT02042027

Contacts
Contact: Bonnie Archer (801) 213-2550 bejarcher@gmail.com

Locations
United States, Utah
John A. Moran Eye Center Not yet recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: Balamurali K. Ambati, M.D., Ph.D., M.B.A.         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Balamurali K Ambati, M.D., Ph.D., M.B.A. University of Utah
  More Information

Publications:

Responsible Party: Balamurali Ambati, Professor of Ophthalmology, University of Utah
ClinicalTrials.gov Identifier: NCT02042027     History of Changes
Other Study ID Numbers: AMB70983
Study First Received: January 17, 2014
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
corneal neovascularization
Gamunex-C
IVI-g
anterior segment inflammation

Additional relevant MeSH terms:
Inflammation
Neovascularization, Pathologic
Corneal Neovascularization
Pathologic Processes
Metaplasia
Corneal Diseases
Eye Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014