FuchsPhase 3DETECT IINCT05275972
Descemet Endothelial Thickness Comparison Trial II
A Phase 3 study testing Ripasudil in people with Fuchs and Fuchs Dystrophy, run by Stanford University at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy
- What is being tested?
- Ripasudil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Jan 2023to 30 Oct 2028
- 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 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
Who cannot join
- 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
Show all 10Show fewer
- >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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Patrick Herrin, Patrick.R.Herrin@hitchcock.org
William Gensheimer, MD
- Recruiting
University of Miami
Palm Beach Gardens, Florida, 33418
Ryan Stanfield, rxs421@med.miami.edu
Ellen Koo, MD
- Recruiting
Stanford University
Palo Alto, California, 94303
Nicole Varnado, MPH, nvarnado@stanford.edu
Jennifer Rose-Nussbaumer, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Emma Iacobucci, Emma.Iacobucci@Pennmedicine.upenn.edu
Bennie Jeng, MD
- Recruiting
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Alice Drew, adrew@willseye.org
Zeba Syed, MD
- Recruiting
Legacy Devers Eye Institute
Portland, Oregon, 97210
Megan Straiko, PhD, 503-413-8377, MESTRAIK@LHS.ORG
Michael Straiko, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Kenia Chavez, 503-494-3475, chavezke@ohsu.edu
Roma Pegany, MD
- Recruiting
University of California Davis
Sacramento, California, 95817
Denise Macias, 916-734-6303, dcmacias@ucdavis.edu
Mathew Margolis, MD
About this study
Official title: Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
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.
- Conditions
- Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy
- Being tested
- Ripasudil, Placebo
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RipasudilDrug
Topical Ripasudil 0.4%
PlaceboDrug
Topical Placebo
| Study group | Role | What they receive |
|---|---|---|
| DMEK plus topical placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| DSO plus topical ripasudil 0.4% | Experimental | Not described Receives: Drug: Ripasudil |
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 (BSCVA)
Measured: 12 months
Secondary outcomes (2)
Best spectacle-corrected visual acuity (BSCVA)
Best spectacle-corrected visual acuity (BSCVA)
Measured: 3, 6 and 24 months
Endothelial cell density
Endothelial cell density
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 posted11 Mar 2022
- Study start23 Jan 2023
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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, Devers Eye Institute
- 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
- NCT05275972
- Sponsor's protocol ID
- 20220590-II
- Acronym
- DETECT II
- 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 40789362Lin CC, Chamberlain W, Benetz BA, Gensheimer W, Li JY, Jeng BH, Clover J, Varnado N, Abdelrahman S, Srinivasan A, Syed ZA, Koo EH, Arnold BF, Lietman TM, Lass J, Rose-Nussbaumer J. Descemet Endothelial Thickness Comparison Trial II (DETECT II): multicentre, outcome assessor-masked, placebo-controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) to Descemet stripping only (DSO) with adjunctive ripasudil for Fuchs dystrophy. BMJ Open Ophthalmol. 2024 Oct 1;9(1):e001725. doi: 10.1136/bmjophth-2024-001725.
PubMed 39353677
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
- NCT05275972
- Acronym / sponsor ID
- DETECT II / 20220590-II
- Conditions
- Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- 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, Devers Eye Institute
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 11 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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMEK plus topical placebo | Placebo comparator | Drug: Placebo |
| DSO plus topical ripasudil 0.4% | Experimental | Drug: Ripasudil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| RipasudilTopical Ripasudil 0.4% | Drug | DSO plus topical ripasudil 0.4% |
| PlaceboTopical Placebo | Drug | DMEK plus topical placebo |
Primary outcome
Best spectacle-corrected visual acuity (BSCVA)
Time frame: 12 months
Best spectacle-corrected visual acuity (BSCVA)
2 secondary outcomes
Best spectacle-corrected visual acuity (BSCVA)
Time frame: 3, 6 and 24 months
Endothelial cell density
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.
- Derived from this study: PubMed 39353677Lin CC, Chamberlain W, Benetz BA, Gensheimer W, Li JY, Jeng BH, Clover J, Varnado N, Abdelrahman S, Srinivasan A, Syed ZA, Koo EH, Arnold BF, Lietman TM, Lass J, Rose-Nussbaumer J. Descemet Endothelial Thickness Comparison Trial II (DETECT II): multicentre, outcome assessor-masked, placebo-controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) to Descemet stripping only (DSO) with adjunctive ripasudil for Fuchs dystrophy. BMJ Open Ophthalmol. 2024 Oct 1;9(1):e001725. doi: 10.1136/bmjophth-2024-001725.
Related trials for Fuchs
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Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
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Active, not recruitingPhase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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The Belgian Endothelial Surgical Transplant of the Cornea
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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.
Jennifer Rose-Nussbaumer, MD principal investigator
Stanford University
8 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 Ripasudil in people with Fuchs and Fuchs Dystrophy, run by Stanford University at 8 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 5 inclusion and 10 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: looking for participants now, 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 8 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?
Contact Nicole Varnado, MPH (650-725-1688, nvarnado@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best spectacle-corrected visual acuity (BSCVA) (time frame: 12 months). 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 NCT05275972, which also lists 2 linked publications.
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.