OPTIMISE: Optimized Immunosuppression for Corneal Transplantation: a multi-centre randomized controlled clinical trial

Phase 1

Recruiting

Conditions: Corneal transplantation, Descemet's Membrane Endothelial Keratoplasty (DMEK)
MedDRA version: 21.1Level: LLTClassification code: 10011016Term: Corneal graft Class: 10042613
MedDRA version: 22.0Level: PTClassification code: 10081851Term: Corneal graft failure Class: 100000004863
MedDRA version: 20.1Level: PTClassification code: 10011017Term: Corneal graft rejection Class: 100000004870
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: CTIS2022-500109-41-00

Lead Sponsor: niversity Hospital Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 442

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, Previous corneal graft in the study eye, Known sensitivity or contraindication to the ingredients in the study medications, History of uveitis or herpetic keratitis, Human Leukocyte Antigen (HLA) typed allograft, Pregnancy (current and planned) or lactation, Use of other local or systemic immunosuppressive drugs

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate an evidence-based short- and long-term immunosuppressive protocol for DMEK that minimizes IOP elevation and endothelial cell loss.;Secondary Objective: Evaluate the cost-effectiveness of the immunosuppressive protocols with a time horizon of two years (trial-based cost-effectiveness evaluation, TBEE), Model the lifelong cost-effectiveness of the immunosuppressive protocols (model-based cost effectiveness evaluation, MBEE)., Evaluate patient experiences and satisfaction with the immunosuppressive protocols;Primary end point(s): Step I (Year 1): The primary outcome of Step I, IOP elevation, is the development of IOP elevation, defined as an IOP =24 mmHg or an increase of =10 mmHg compared to preoperative baseline at any postoperative examination., Step II (Year 2): The primary outcome of Step II is the Endothelial Cell Loss (ECL) in the second year. This will be calculated based on specular microscopy images of the central cornea taken at 12 months and 24 months post-operatively

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Rejection-free graft survival;Secondary end point(s):Short-term trial-based economic evaluation (TBEE, cost-effectiveness analyses);Secondary end point(s):Life-long model-based economic evaluation (MBEE, cost-effectiveness analyses);Secondary end point(s):Patient-reported outcome measures (PROMs): vision-specific and generic health-related quality of life, patient experiences and satisfaction, and compliance;Secondary end point(s):Best-corrected distance visual acuity (BCDVA);Secondary end point(s):Structural outcomes: corneal, central macular, and retinal nerve fiber layer thickness