Glaucoma Following SurgeryPhase 1/2NCT05180994
Topical Infliximab in Eyes With Penetrating Keratoplasty
A Phase 1/2 study testing Topical infliximab and No topical infliximab in people with Glaucoma Following Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma Following Surgery
- What is being tested?
- Topical infliximab and No topical infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2022to 1 Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Zobelle Tchouaga, 514 890-8000 ext. 11553, zobelle.tchouaga.tongambou.chum@ssss.gouv.qc.ca
About this study
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.
Read the 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.
Regarding statistical analysis, the primary and secondary outcomes of the study will be described, including : percentage of patients presenting with a thinning of mean retinal nerve fiber thickness measured using OCT (optical coherence tomography), with thinning in four quadrants (inferior, superior, nasal, temporal); proportion of patients without glaucoma over time; mean change in BCVA (best corrected visual acuity) compared to baseline BCVA; OSDI (Ocular Surface Disease Index) score evolution over time; quantification of ocular surface inflammation; quantification of anterior chamber inflammation; epithelial healing time; and incidence of epithelial keratitis.
Visual acuity values will be converted to LogMAR. Data will be presented as numbers and percentages for categorical variables, and as mean ± standard deviation for continuous variables. Comparison between experimental and comparison groups will be done using student's t test if distribution is parametric, and Mann-Whitney U test if distribution is non-parametric. The Kaplan-Meier curve will be used in order to illustrate the proportion of patients without glaucoma over time. An interim statistical analysis will be done once n=10 patients will have completed the full 6 months of study follow-up. A statistical significance level of α=0.05 will be used.
- Conditions
- Glaucoma Following Surgery
- Being tested
- Topical infliximab, No topical infliximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical infliximabDrug
Also called Remicade
Infliximab eye drops (10mg/ml) administered four (4) times per day for three (3) months.
No topical infliximabOther
No treatment with infliximab.
| Study group | Role | What they receive |
|---|---|---|
| Topical infliximab following PKP surgery | Experimental | 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. Receives: Drug: Topical infliximab |
| No topical infliximab following PKP surgery | Active comparator | 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. Receives: Other: No topical infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications associated to PKP surgery
Number and type of complications associated to PKP surgery (graft loss, infectious keratitis, graft failure, corneal melting…)
Measured: 6 months
Complications associated to infliximab use
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).
Measured: 6 months
Secondary outcomes (8)
Mean retinal nerve fiber thickness
Percentage of patients presenting with a thinning of mean retinal nerve fiber thickness measured using OCT, with thinning in four quadrants (inferior, superior, nasal, temporal).
Measured: 6 months
Occurrence of glaucoma
Proportion of patients without glaucoma over time.
Measured: 6 months
Best Corrected Visual Acuity (BCVA)
Mean change in BCVA compared to baseline BCVA, measured using a Snellen chart.
Measured: 6 months
Ocular surface symptoms
Ocular surface symptoms as assessed by the Ocular Surface Disease Index (OSDI) questionnaire, ranging from 0 to 100, where a higher score indicates increased disease severity.
Measured: 6 months
Quantification of ocular surface inflammation
Conjunctival erythema on a scale of 0 to 4, where a higher score indicates increased disease severity.
Measured: 6 months
Quantification of anterior chamber inflammation
Quantification of anterior chamber inflammation according to the SUN definition (Standardization of Uveitis Nomenclature).
Measured: 6 months
Epithelial healing time
Number of days between surgery and absence of epithelial deficit.
Measured: 6 months
Incidence of epithelial keratitis
Incidence of epithelial keratitis assessed using the National Eye Institute Score (0-15).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 May 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma Following SurgeryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de recherche en ophtalmologie de l'Université de Montréal, Maisonneuve-Rosemont Hospital, Niagara Health System, Prism Eye Institute, Ottawa Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Marie-Claude Robert, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180994
- Sponsor's protocol ID
- CE 21.232
- Other IDs
- MP-02-2021-9824
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Infliximab in Eyes With Penetrating Keratoplasty
- ClinicalTrials.gov ID
- NCT05180994
- Acronym / sponsor ID
- CE 21.232
- Conditions
- Glaucoma Following Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Fonds de recherche en ophtalmologie de l'Université de Montréal, Maisonneuve-Rosemont Hospital, Niagara Health System, Prism Eye Institute, Ottawa Hospital Research Institute
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Regarding statistical analysis, the primary and secondary outcomes of the study will be described, including : percentage of patients presenting with a thinning of mean retinal nerve fiber thickness measured using OCT (optical coherence tomography), with thinning in four quadrants (inferior, superior, nasal, temporal); proportion of patients without glaucoma over time; mean change in BCVA (best corrected visual acuity) compared to baseline BCVA; OSDI (Ocular Surface Disease Index) score evolution over time; quantification of ocular surface inflammation; quantification of anterior chamber inflammation; epithelial healing time; and incidence of epithelial keratitis.
Visual acuity values will be converted to LogMAR. Data will be presented as numbers and percentages for categorical variables, and as mean ± standard deviation for continuous variables. Comparison between experimental and comparison groups will be done using student's t test if distribution is parametric, and Mann-Whitney U test if distribution is non-parametric. The Kaplan-Meier curve will be used in order to illustrate the proportion of patients without glaucoma over time. An interim statistical analysis will be done once n=10 patients will have completed the full 6 months of study follow-up. A statistical significance level of α=0.05 will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical infliximab following PKP surgery | Experimental | Drug: Topical infliximabAdditionally 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. |
| No topical infliximab following PKP surgery | Active comparator | Other: No topical infliximabPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical infliximabAlso: RemicadeInfliximab eye drops (10mg/ml) administered four (4) times per day for three (3) months. | Drug | Topical infliximab following PKP surgery |
| No topical infliximabNo treatment with infliximab. | Other | No topical infliximab following PKP surgery |
Primary outcome
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…)
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).
8 secondary outcomes
Mean retinal nerve fiber thickness
Time frame: 6 months
Occurrence of glaucoma
Time frame: 6 months
Best Corrected Visual Acuity (BCVA)
Time frame: 6 months
Ocular surface symptoms
Time frame: 6 months
Quantification of ocular surface inflammation
Time frame: 6 months
Quantification of anterior chamber inflammation
Time frame: 6 months
Epithelial healing time
Time frame: 6 months
Incidence of epithelial keratitis
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Claude Robert, MD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical infliximab and No topical infliximab in people with Glaucoma Following Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zobelle Tchouaga (514 890-8000 ext. 11553, zobelle.tchouaga.tongambou.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications associated to PKP surgery (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.