Topical Infliximab in Eyes With Penetrating Keratoplasty
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Complications associated to infliximab use
Study Overview
Brief Summary
Penetrating keratoplasty is a cornea surgery involving several inflammatory complications, of which the most important is glaucoma. Researchers wish to determine whether it is safe to administer infliximab (an anti-inflammatory drug) eye drops after surgery, and whether this eye drop could prevent the occurrence of glaucoma.
Detailed Description
This is a prospective, multicenter, double-arm open clinical trial of 50 patients receiving a first penetrating keratoplasty (PKP) surgery, recruited to receive infliximab drops post-operatively.
The current study aims to evaluate whether using topical infliximab 10mg/ml eye drops is safe and efficient to prevent the emergence of glaucoma of inflammatory etiology in patients with PKP. This study is examining a new form of delivering infliximab (as eye drops instead of injections in the veins). 25 patients who will be undergoing PKP surgery will be recruited to receive infliximab drops as a part of this study.
The research hypothesis is that topical infliximab used during the PKP post-operative period will be safe, and could protect against the occurrence of glaucoma.
For comparison purposes, if some patients are not qualified to receive infliximab or should they refuse to receive infliximab, these patients will still be offered to follow the same follow-up schedule, questionnaires, examinations and non-invasive tests (excluding lab work), as patients who will be receiving infliximab. The number of patients in this control group will also be limited to 25 patients.
During the treatment period, patients in the interventional arm of the study will be receiving topical infliximab 10mg/ml eye drops four times per day, for a duration of 3 months. Patients will be monitored for another 3 months after cessation of the study drug. The total study duration for each patient will be 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 80 years;
- •First corneal transplant surgery;
- •Capable of providing informed consent;
- •Capable of administering eye medication or access to a caregiver able and willing to administer the eye medication for the patient.
Exclusion Criteria
- •Active ocular infection;
- •Past corneal transplant (any technique);
- •Advanced glaucoma or macular disease;
- •Active or latent systemic infection (tuberculosis, histoplasmosis, coccidioidomycosis, cytomegalovirus, pneumocystis, aspergillosis or hepatitis B);
- •Malignancy diagnosed in the past 5 years (any kind);
- •Demyelinating disease;
- •History or current diabetes mellitus (controlled or uncontrolled) or heart failure (New York Heart Association class III or IV);
- •Pregnancy or breastfeeding;
- •Allergy to infliximab or to a compound of its topical formulation;
- •Significant anomaly of complete blood count or hepatic enzymes;
- •Current or anterior use of anti-TNF-α medication or other anti-inflammatory biologics.
Arms & Interventions
Topical infliximab following PKP surgery
Additionally to standard post-operative regimen, patients who will be undergoing their first PKP surgery and who meet all inclusion and no exclusion criteria will be included in the experimental group. These patients will administer topical infliximab four times per day for 3 months.
Intervention: Topical infliximab (Drug)
No topical infliximab following PKP surgery
Patients who will be undergoing their first PKP surgery, but who are not qualified to receive infliximab or who refuse to receive infliximab, will be included in the control group. These patients will only administer the standard post-operative regimen following their PKP surgery and will not administer topical infliximab. They will be followed with the same follow-up schedule, questionnaires, examinations and non-invasive tests (excluding lab work) as patients in the interventional group.
Intervention: No topical infliximab (Other)
Outcomes
Primary Outcomes
Complications associated to infliximab use
Time Frame: 6 months
Number and type of complications associated with infliximab use (serious infections, allergic reactions, heart failure, blood problems, nervous system disorders, malignancies…; these complications have been observed with intravenous infliximab administration).
Complications associated to PKP surgery
Time Frame: 6 months
Number and type of complications associated to PKP surgery (graft loss, infectious keratitis, graft failure, corneal melting…)
Secondary Outcomes
- Occurrence of glaucoma(6 months)
- Best Corrected Visual Acuity (BCVA)(6 months)
- Epithelial healing time(6 months)
- Incidence of epithelial keratitis(6 months)
- Mean retinal nerve fiber thickness(6 months)
- Ocular surface symptoms(6 months)
- Quantification of ocular surface inflammation(6 months)
- Quantification of anterior chamber inflammation(6 months)