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NCT05134480: DEKS

Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss

Completed NA Results posted Last updated 16 April 2026
What this trial tests

NA trial testing Descemet membrane endothelial keratoplasty in Corneal Endothelial Decompensation in 1,097 participants. Completed in 15 September 2025.

Timeline
21 January 2022
Primary endpoint
15 July 2025
15 September 2025

Quick facts

Lead sponsorCase Western Reserve University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment1,097
Start date21 January 2022
Primary completion15 July 2025
Estimated completion15 September 2025
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Case Western Reserve University

Who can join

Adults 30 to 90, any sex, with Corneal Endothelial Decompensation or Fuchs' Endothelial Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Graft Failure Primary · 1 year

Graft failure is defined as the occurrence of one of the following: a graft which requires replacement for any reason or the recipient cornea remains cloudy after surgery without clearing for 8 weeks or longer

GroupValue95% CI
Cornea From Donor Without Diabetes32
Cornea From Donor With Diabetes15
Endothelial Cell Density Secondary · 1 year

Central corneal endothelial cell density assessed with specular microscopy

GroupValue95% CI
Cornea From Donor Without Diabetes1927± 498
Cornea From Donor With Diabetes1920± 496

Adverse events — posted to ClinicalTrials.gov

Time frame: from enrollment until end of follow-up, up to 15 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cornea From Donor With Diabetes
Serious: 4/912 (0%)
Deaths: 7/912
Cornea From Donor Without Diabetes
Serious: 2/509 (0%)
Deaths: 4/509

Serious adverse events (6 terms)

ReactionSystemCornea From Donor With Dia…Cornea From Donor Without …
Retinal detachmentEye disorders
Herpes simplex viral keratitisEye disorders
Pseudoendophthalmitis (likely cytomegalovirus keratouveitis)Eye disorders
Vitreous hemorrhage/choroidal effusionsEye disorders
Deep vein thrombosisBlood and lymphatic system disorders
Corneal keratitisEye disorders
Other adverse events (4 terms — click to expand)

ReactionSystemCornea From Donor With Dia…Cornea From Donor Without …
Postoperative air or gas injection to promote graft attachmentEye disorders
Intraocular pressure > 25 mm HgEye disorders
Clouded recipient stroma noted at any timepointEye disorders
Surgical complicationsEye disorders

Most-reported serious reactions: Retinal detachment, Herpes simplex viral keratitis, Pseudoendophthalmitis (likely cytomegalovirus keratouveitis), Vitreous hemorrhage/choroidal effusions, Deep vein thrombosis, Corneal keratitis.

Data from ClinicalTrials.gov NCT05134480 adverse events section.

Sponsor's own description

This double-masked multi-center trial will evaluate the association of diabetes in the cornea donor with transplant success and loss of endothelial cells through 1 year following Descemet membrane endothelial keratoplasty (DMEK). Study eyes are assigned to receive either a cornea from a donor without diabetes or a cornea from a donor with diabetes.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Squishy matters - Corneal mechanobiology in health and disease.
    Thomasy SM, Leonard BC, Greiner MA, Skeie JM, et al · · 2024 · cited 32× · PMID 38176611 · DOI 10.1016/j.preteyeres.2023.101234
  2. Type II Diabetes Mellitus Causes Extracellular Matrix Alterations in the Posterior Cornea That Increase Graft Thickness and Rigidity.
    Kingsbury KD, Skeie JM, Cosert K, Schmidt GA, et al · · 2023 · cited 10× · PMID 37326594 · DOI 10.1167/iovs.64.7.26
  3. Diabetes Endothelial Keratoplasty Study: Methods and Impact on the Use of Corneas From Donors With Diabetes for Descemet Membrane Endothelial Keratoplasty.
    Price MO, Price MO, Szczotka-Flynn LB, Bauza CE, et al · · 2026 · cited 5× · PMID 39808526 · DOI 10.1097/ico.0000000000003776
  4. Therapeutic future of Fuchs endothelial corneal dystrophy: An ongoing way to explore.
    Liu JX, Chiang TL, Hung KF, Sun YC. · · 2024 · cited 5× · PMID 38654984 · DOI 10.4103/tjo.tjo-d-23-00115
  5. Donor Diabetes and 1-Year Descemet Membrane Endothelial Keratoplasty Success Rate: A Randomized Clinical Trial.
    Price FW, Szczotka-Flynn LB, Price MO, Bauza CE, et al · · 2025 · cited 2× · PMID 41105094 · DOI 10.1001/jamaophthalmol.2025.4253
  6. Endothelial Cell Loss 1 Year After Successful DMEK in the Diabetes Endothelial Keratoplasty Study: A Randomized Clinical Trial.
    Lass JH, Benetz BA, Verdier DD, Szczotka-Flynn LB, et al · · 2025 · cited 1× · PMID 41105099 · DOI 10.1001/jamaophthalmol.2025.4261

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05134480.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing