E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Corneal disease/opacification treated with corneal endothelial transplantation (DSAEK or DMEK surgery), and the medical treatment is anti-inflammatory eye drops to treat (and prevent) intraocular inflammation and development of cystoid macular edema. |
|
E.1.1.1 | Medical condition in easily understood language |
In this trial, we will study anti-inflammatory eye drops used in relation to part-thickness corneal transplantation - to place a part-thickness donor graft on the inside of the cornea. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Compare postoperative intraocular inflammation and affection of the macula between two different medication regimens after corneal endothelial transplantation (DSAEK or DMEK surgery) |
|
E.2.2 | Secondary objectives of the trial |
• Compare central macular thickness and the risk of cystoid macular edema • Compare visual outcome • Compare intraocular pressure • Compare corneal endothelial cell density • Compare patient-reported outcome measures ---between the medication groups |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants are eligible to be included in the study if all of the following criteria apply: • Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit. • Scheduled for DSAEK or DMEK • Ability to cooperate fairly well during the examinations • Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.
|
|
E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply: • Contraindications for use of any medication (e.g. allergy, pregnancy, breastfeeding) o Pregnancy or possible pregnancy during the study period is considered an exclusion criterion and pregnancy and contraception are commented in more detail in section 8.5 • Preoperative macular edema and/or ongoing treatment for macular edema • Re-transplantation • In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve) • Aphakic eyes • Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)
For patients scheduled for corneal endothelial keratoplasty in both eyes, only the first operated eye will be included, however, both eyes will be examined.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Central macular thickness and macular cysts on optical coherence tomography
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Preoperatively, 1 week, 4 weeks, 2 months, 2 years after surgery |
|
E.5.2 | Secondary end point(s) |
• • Laser flare
• Peroperative factors (e.g. operation time (minutes), iris lesion (none, some, much), pigment loss (none, some, much), intraocular manipulation ((none, some, much)) • IOP in mmHg (applanation and iCare) • Corrected distance visual acuity (in logMAR) • Corneal endothelial cell density (measured with confocal microscopy, in cells/mm2) • COMTol questionnaire for ocular medication
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Preoperatively, peroperatively, 1 day, 1 week, 4 weeks, 2 months, 2 years after surgery |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Health economics of the two medication regimens |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |