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

Phase 1

Withdrawn

• Conditions: Corneal Neovascularization; Corneal Graft Failure; Anterior Segment Inflammation
• Interventions: Drug: Gamunex-C

• Registration Number: NCT02042027
• Lead Sponsor: University of Utah

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 Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-22
• Study Start: 2014-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Gamunex-C	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
Group B	Gamunex-C	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.

Primary Outcome Measures

Name	Time	Method
Ability to regress neovascularization	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)

Secondary Outcome Measures

Name	Time	Method
Need for rescue treatment in standard of care group	week 52	need for rescue treatment in the standard of care group through week 52
Mean number of injections through week 52	week 52	mean number of injections performed per patient through week 52 in patients receiving subconjunctival IVIg (Gamunex-C) injections
Ability to regress neovascularization and promote graft survival	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)
Visual outcome at week 28	Week 28	visual outcome (by ETDRS chart) at week 28 in both treatment groups
Need for immunosuppression	week 52	need for immunosuppression at week 52 in both treatment groups
Effect on corneal infections	Week 52	effect on corneal infections or other side effects through week 52 in both treatment groups
Visual outcome at week 52	Week 52	visual outcome (by ETDRS chart) at week 52 in both treatment groups
Mean number of injections through week 28	week 28	mean number of injections performed per patient through weeks 28

Trial Locations

Locations (1)

John A. Moran Eye Center; 🇺🇸 Salt Lake City, Utah, United States