FuchsPhase 3DETECT INCT05289661
Descemet Endothelial Thickness Comparison Trial I
A Phase 3 study testing Topical Ripasudil in people with Fuchs, run by Stanford University at 7 sites in United States.
Trial summary
Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs
- What is being tested?
- Topical Ripasudil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Jul 2022to 30 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata
- Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)
- Dysfunctional endothelium from prior graft failure after PKP or EK
- Controlled uveitis (defined as quiet for > 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis
- Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP < 5 mmHg) or no glaucoma
- Good candidate for corneal transplantation for either DMEK or UT-DSAEK
- Willingness to participate
- Age greater than 18 years
Who cannot join
- Aphakia, or 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
- Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
- Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology
- Pregnancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
University of Miami
Palm Beach Gardens, Florida, 33418
Stanford University
Palo Alto, California, 94303
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Oregon Health & Science University
Portland, Oregon, 97239
University of California Davis
Sacramento, California, 95817
About this study
Official title: Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.
- Conditions
- Fuchs
- Being tested
- Topical Ripasudil, Topical Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical RipasudilDrug
Also called Ripasudil
To determine the effect of rho-kinase inhibitors on endothelial cell loss
Topical PlaceboDrug
Also called Placebo
topical Placebo
| Study group | Role | What they receive |
|---|---|---|
| UT-DSAEK plus topical ripasudil | Experimental | This arm will receive UT-DSAEK plus topical ripasudil 0.4% Receives: Drug: Topical Ripasudil |
| UT-DSAEK plus topical placebo | Placebo comparator | This arm will receive UT-DSAEK plus topical placebo Receives: Drug: Topical Placebo |
| DMEK plus topical ripasudil | Experimental | This arm will receive DMEK plus topical ripasudil 0.4% Receives: Drug: Topical Ripasudil |
| DMEK plus topical placebo | Placebo comparator | This arm will receive DMEK plus topical placebo Receives: Drug: Topical Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best spectacle-corrected visual acuity (BSCVA)
Best spectacle-corrected visual acuity
Measured: 12 months
Endothelial cell loss
Change between endothelial density at baseline versus density at 12 months
Measured: 12 months
Secondary outcomes (1)
Best spectacle-corrected visual acuity (BSCVA)
Best spectacle-corrected visual acuity
Measured: 3, 6 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start15 Jul 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FuchsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, University of California, San Francisco, University of California, Davis, Case Western Reserve University, Dartmouth-Hitchcock Medical Center, University of Pennsylvania, University of Miami, Wills Eye Hospital
- Responsible party
- Principal investigator, Jennifer Rose-Nussbaumer, Stanford University
- Investigators
- Jennifer Rose-Nussbaumer, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289661
- Sponsor's protocol ID
- 20220590-I
- Acronym
- DETECT I
- Status last verified
- Aug 2026
- First submitted
- 2 Mar 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Patel SV, Gupta N, Bhogal M, Jurkunas UV, Okumura N, Romano V, Allan BD, Baratz KH, Basak SK, Baydoun L, Chamberlain W, Chaurasia S, Colby K, Cursiefen C, Giobellina T, Greiner MA, Hjortdal J, Kobayashi A, Kocaba V, Koo EH, Lee WB, Livny E, Males JJ, Matthaei M, Mehta JS, Mejia L, Moloney G, Mootha VV, Muraine M, Oie Y, Pereira NC, Price FW Jr, Srikumaran D, Terry MA, Veldman PB, Verdier DD, Vaddavalli PK, Pineda R 2nd. Delphi-Based Global Consensus on Fuchs Endothelial Corneal Dystrophy. An Endothelial Keratoplasty Learners Group Initiative. Am J Ophthalmol. 2025 Dec;280:130-143. doi: 10.1016/j.ajo.2025.08.012. Epub 2025 Aug 9.
PubMed 40789362
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
- ClinicalTrials.gov ID
- NCT05289661
- Acronym / sponsor ID
- DETECT I / 20220590-I
- Conditions
- Fuchs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, University of California, San Francisco, University of California, Davis, Case Western Reserve University, Dartmouth-Hitchcock Medical Center, University of Pennsylvania, University of Miami, Wills Eye Hospital
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UT-DSAEK plus topical ripasudil | Experimental | Drug: Topical RipasudilThis arm will receive UT-DSAEK plus topical ripasudil 0.4% |
| UT-DSAEK plus topical placebo | Placebo comparator | Drug: Topical PlaceboThis arm will receive UT-DSAEK plus topical placebo |
| DMEK plus topical ripasudil | Experimental | Drug: Topical RipasudilThis arm will receive DMEK plus topical ripasudil 0.4% |
| DMEK plus topical placebo | Placebo comparator | Drug: Topical PlaceboThis arm will receive DMEK plus topical placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata
- Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)
- Dysfunctional endothelium from prior graft failure after PKP or EK
- Controlled uveitis (defined as quiet for > 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis
- Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP < 5 mmHg) or no glaucoma
Key exclusion criteria (5 listed)
- Aphakia, or 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
- Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
- Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical RipasudilAlso: RipasudilTo determine the effect of rho-kinase inhibitors on endothelial cell loss | Drug | DMEK plus topical ripasudil, UT-DSAEK plus topical ripasudil |
| Topical PlaceboAlso: Placebotopical Placebo | Drug | DMEK plus topical placebo, UT-DSAEK plus topical placebo |
Primary outcome
Best spectacle-corrected visual acuity (BSCVA)
Time frame: 12 months
Best spectacle-corrected visual acuity
Endothelial cell loss
Time frame: 12 months
Change between endothelial density at baseline versus density at 12 months
1 secondary outcome
Best spectacle-corrected visual acuity (BSCVA)
Time frame: 3, 6 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 40789362Patel SV, Gupta N, Bhogal M, Jurkunas UV, Okumura N, Romano V, Allan BD, Baratz KH, Basak SK, Baydoun L, Chamberlain W, Chaurasia S, Colby K, Cursiefen C, Giobellina T, Greiner MA, Hjortdal J, Kobayashi A, Kocaba V, Koo EH, Lee WB, Livny E, Males JJ, Matthaei M, Mehta JS, Mejia L, Moloney G, Mootha VV, Muraine M, Oie Y, Pereira NC, Price FW Jr, Srikumaran D, Terry MA, Veldman PB, Verdier DD, Vaddavalli PK, Pineda R 2nd. Delphi-Based Global Consensus on Fuchs Endothelial Corneal Dystrophy. An Endothelial Keratoplasty Learners Group Initiative. Am J Ophthalmol. 2025 Dec;280:130-143. doi: 10.1016/j.ajo.2025.08.012. Epub 2025 Aug 9.
Related trials for Fuchs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Rose-Nussbaumer, MD principal investigator
Stanford University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical Ripasudil in people with Fuchs, run by Stanford University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best spectacle-corrected visual acuity (BSCVA) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.