What side effects are associated with this type of intervention?

The most common treatments for Fuchs' Dystrophy include corneal transplant surgeries such as ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), as well as the use of Rho-Kinase inhibitors. UT-DSAEK and DMEK can lead to complications such as intraocular lens calcifications, which may result in reduced visual acuity. Rho-Kinase inhibitors, while effective in reducing endothelial cell loss, can cause significant corneal flattening, as observed in a case where a child developed 6.5 diopters of corneal flattening. These side effects highlight the importance of careful monitoring and management during treatment.

What prior FDA approvals exist?

FDA-approved treatments for Fuchs' Dystrophy primarily include corneal transplant surgeries such as Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK). These procedures involve replacing the diseased endothelial layer of the cornea with healthy donor tissue. Additionally, Rho-Kinase Inhibitors, which aim to reduce endothelial cell loss by inhibiting the Rho-Kinase enzyme, are being studied but are not yet FDA-approved specifically for Fuchs' Dystrophy.

What other types of research exist?

Promising novel alternatives for Fuchs' Dystrophy treatment in 2024 include: 1) Cultivated endothelial cell transplantation, which involves growing corneal endothelial cells in a lab and transplanting them to the patient's eye, potentially offering a less invasive option compared to traditional transplants. 2) Gene therapy approaches targeting the underlying genetic mutations responsible for Fuchs' Dystrophy, aiming to correct or mitigate the disease at a molecular level. 3) Advanced pharmacological agents beyond rho-kinase inhibitors, such as novel small molecules or biologics that promote endothelial cell regeneration and reduce cell loss more effectively.

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Ripasudil for Fuchs' Dystrophy (DETECT I Trial)

Q: What is the mechanism of action of this treatment?

Fuchs' Dystrophy primarily affects the endothelial cells of the cornea, leading to vision impairment. Corneal transplant surgeries like ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) replace the damaged endothelial layer with healthy donor tissue, thereby restoring corneal clarity and improving vision. Rho-Kinase inhibitors work by inhibiting the Rho-Kinase enzyme, which helps reduce endothelial cell loss and promotes cell survival. These treatments are crucial as they directly target the underlying cause of Fuchs' Dystrophy, offering significant improvements in visual outcomes and quality of life for patients.

Phase 3

Recruiting

Led By Jennifer Rose-Nussbaumer, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Dysfunctional endothelium from prior graft failure after PKP or EK

Willingness and ability to undergo corneal transplantation

Must not have

Fellow eye visual acuity <20/200

Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6 and 24 months

Awards & highlights

Pivotal Trial

Summary

This trial is evaluating different corneal transplant methods and a medication to see which approach improves vision and helps protect eye cells.

Who is the study for?

This trial is for adults over 18 with Fuchs' Dystrophy or other corneal diseases, who are good candidates for corneal transplant surgery and willing to follow the study's medication regimen. It excludes pregnant individuals, those with significant eye conditions in the non-study eye, recent cataract surgery, or inability to follow post-op instructions.

What is being tested?

DETECT I evaluates visual outcomes of two corneal transplant surgeries (UT-DSAEK and DMEK) and examines if rho-kinase inhibitors can reduce cell loss after these procedures. Participants will be randomly assigned to receive either topical Ripasudil or a placebo in a masked setup.

What are the potential side effects?

While specific side effects are not listed here, typical concerns may include irritation from topical medications like Ripasudil, potential complications from surgery such as infection or rejection of the transplant, and general risks associated with any ocular procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a previous cornea transplant that didn't work.

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I am willing and able to have a cornea transplant.

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I am older than 18 years.

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I have severe corneal swelling or guttata from Fuchs' dystrophy extending beyond the center.

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My glaucoma is managed with medication or surgery, and my eye pressure is stable.

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I have a specific type of corneal swelling or dysfunction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My other eye's vision is worse than 20/200.

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My eye has iris adhesion to the angle in more than 3 clock hours.

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I have serious eye problems affecting my vision.

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I can follow post-surgery care instructions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Endothelial cell loss

Secondary study objectives

Best spectacle-corrected visual acuity (BSCVA)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: UT-DSAEK plus topical ripasudilExperimental Treatment1 Intervention

This arm will receive UT-DSAEK plus topical ripasudil 0.4%

Group II: DMEK plus topical ripasudilExperimental Treatment1 Intervention

This arm will receive DMEK plus topical ripasudil 0.4%

Group III: DMEK plus topical placeboPlacebo Group1 Intervention

This arm will receive DMEK plus topical placebo

Group IV: UT-DSAEK plus topical placeboPlacebo Group1 Intervention

This arm will receive UT-DSAEK plus topical placebo

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Fuchs' Dystrophy primarily affects the endothelial cells of the cornea, leading to vision impairment. Corneal transplant surgeries like ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) replace the damaged endothelial layer with healthy donor tissue, thereby restoring corneal clarity and improving vision. Rho-Kinase inhibitors work by inhibiting the Rho-Kinase enzyme, which helps reduce endothelial cell loss and promotes cell survival. These treatments are crucial as they directly target the underlying cause of Fuchs' Dystrophy, offering significant improvements in visual outcomes and quality of life for patients.

Outcomes of Descemet membrane endothelial keratoplasty, Descemet stripping automated endothelial keratoplasty and penetrating keratoplasty from a single centre study.