OPTIMISE — safer steroid plans after DMEK cornea transplant

Optimized Immunosuppression for Corneal Transplantation: A Multi-center Randomized Controlled Clinical Trial

This study tests whether using a milder steroid eye drop plan or stopping steroids earlier after DMEK can still prevent graft rejection while reducing the risk of high eye pressure in adults receiving corneal transplants.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 342 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Maastricht University Medical Center (other)
• Locations: 8 sites (Apeldoorn, Gelderland and 7 other locations)
• Trial ID: NCT05716945 on ClinicalTrials.gov

What this trial studies

OPTIMISE is a phase 4 interventional trial enrolling adults listed for DMEK in the Netherlands to compare different postoperative steroid strategies (dexamethasone 0.1%, fluorometholone 0.1%, or stopping steroids). Participants will follow an assigned steroid regimen after their endothelial keratoplasty and attend scheduled follow-up visits to monitor graft health and intraocular pressure. The primary goal is to find an evidence-based, cost-effective regimen that prevents rejection but lowers steroid-induced side effects. Outcomes include rates of rejection, changes in intraocular pressure, and treatment-related complications.

Who should consider this trial

Good fit: Adults aged 21 or older who are registered on the NOTR as candidates for DMEK and who can complete follow-up without contraindications to the study medications are the intended participants.

Not a fit: Patients with prior corneal grafts in the study eye, history of uveitis or herpes simplex, HLA-typed allografts, current pregnancy or lactation, or those on other systemic or local immunosuppressants are unlikely to qualify or benefit from the tested regimen changes.

Why it matters

Potential benefit: If successful, patients could have fewer steroid-related side effects such as raised intraocular pressure while maintaining low graft rejection rates.

How similar studies have performed: DMEK itself is well established with low rejection rates, but randomized evidence on milder or shorter steroid regimens after DMEK is limited, so this approach is not yet widely proven.

Eligibility criteria

Inclusion Criteria:

\- Patients aged 21 years or older registered on the NOTR as candidates for DMEK corneal transplantation

Exclusion Criteria:

* Inability to complete follow up or comply with study procedures
* The participant is vulnerable
* Previous corneal graft in the study eye
* Known sensitivity or contraindication to the ingredients in the study medications
* History of uveitis
* History of any herpes simplex infection
* Human Leukocyte Antigen (HLA) typed allograft
* Pregnancy (current and planned) or lactation
* Use of other local or systemic immunosuppressive drugs

Where this trial is running

Apeldoorn, Gelderland and 7 other locations

• Gelre Ziekenhuizen — Apeldoorn, Gelderland, Netherlands (RECRUITING)
• Radboud Universitair Medisch Centrum — Nijmegen, Gelderland, Netherlands (RECRUITING)
• Maastricht Universitair Medisch Centrum+ — Maastricht, Limburg, Netherlands (RECRUITING)
• Amsterdam Universitair Medisch Centrum — Amsterdam, North Holland, Netherlands (RECRUITING)
• Deventer Ziekenhuis — Deventer, Overijssel, Netherlands (RECRUITING)
• Universitair Medisch Centrum Groningen — Groningen, Provincie Groningen, Netherlands (NOT_YET_RECRUITING)
• Leiden Universitair Medisch Centrum — Leiden, South Holland, Netherlands (RECRUITING)
• Universitair Medisch Centrum Utrecht — Utrecht, Utrecht, Netherlands (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Yexin Ye, MD

Conditions: Pseudophakic Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Intraocular Pressure, Descemet Stripping Endothelial Keratoplasty, Cornea