NCT05275972 Descemet Endothelial Thickness Comparison Trial II
| NCT ID | NCT05275972 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Stanford University |
| Condition | Fuchs |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-23 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2023-01-23 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.
Eligibility Criteria
Inclusion Criteria: * Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm * Peripheral endothelial cell count \>1000 cells/mm2 in at least one quadrant * Good surgical candidate for either procedure as determined by the surgeon * Willingness to participate * Age greater than 18 years Exclusion Criteria: * Aphakia, anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK * Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment * Other primary endothelial dysfunction such as PPMD * Visually significant optic nerve or macular pathology * Hypotony (Intraocular pressure \<10mmHg) * Any prior intraocular surgery other than cataract surgery * \>3 clock hours of ANY anterior or posterior synechiae * \>1 quadrant of stromal corneal vascularization * Inability to comply with post-operative instructions (i.e. unable to position) * Pregnancy
Contact & Investigator
Jennifer Rose-Nussbaumer, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05275972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fuchs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05275972 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT05275972 currently recruiting?
Yes, NCT05275972 is actively recruiting participants. Contact the research team at nvarnado@stanford.edu for enrollment information.
Where is the NCT05275972 trial being conducted?
This trial is being conducted at Palo Alto, United States, Sacramento, United States, Palm Beach Gardens, United States, Lebanon, United States and 4 additional locations.
Who is sponsoring the NCT05275972 clinical trial?
NCT05275972 is sponsored by Stanford University. The principal investigator is Jennifer Rose-Nussbaumer, MD at Stanford University. The trial plans to enroll 60 participants.