What is the mechanism of action of this treatment?

Fuchs' Endothelial Corneal Dystrophy (FECD) treatments primarily aim to improve the function of corneal endothelial cells, which are responsible for maintaining corneal transparency by regulating fluid balance. Common treatments include hypertonic saline drops to reduce corneal swelling, and in advanced cases, corneal transplantation to replace damaged endothelial cells. Emerging treatments like STN1010904 ophthalmic suspension potentially target and enhance the function of existing endothelial cells, thereby improving corneal clarity and delaying the need for surgical intervention. This is crucial for FECD patients as it offers a less invasive option to manage symptoms and maintain vision quality.

What side effects are associated with this type of intervention?

Common treatments for Fuchs' Endothelial Corneal Dystrophy (FECD) include hypertonic saline eye drops, which can cause temporary stinging or burning sensations, and corneal transplant surgery, which carries risks such as infection, graft rejection, and vision fluctuations. Treatments similar to STN1010904 ophthalmic suspension, which aim to improve corneal endothelial cell function, may include side effects like eye irritation, redness, and potential allergic reactions. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically targeting corneal endothelial cells for the treatment of Fuchs' Endothelial Corneal Dystrophy (FECD). The primary treatment for advanced FECD remains corneal transplantation, such as Descemet's Stripping Endothelial Keratoplasty (DSEK) or Descemet's Membrane Endothelial Keratoplasty (DMEK). Research is ongoing to find pharmacological treatments, such as the STN1010904 ophthalmic suspension, which aims to improve endothelial cell function and delay the need for surgical intervention.

What other types of research exist?

Promising novel alternatives to STN1010904 ophthalmic suspension for Fuchs' Dystrophy patients include: 1) CsA-PLGA drug delivery systems, which have shown efficacy in preventing postoperative fibrosis and maintaining filtration pathways in ocular surgeries. 2) Ocular surface modulators, which have demonstrated potential in restoring corneal cells damaged by dry eye conditions. 3) Tacrolimus-loaded PEG-Cholecalciferol based micelles, which have shown significant reduction in corneal inflammation and restoration of corneal epithelial thickness in preclinical models. These alternatives are in various stages of research and may offer new therapeutic options for FECD patients.

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STN1010904 Eye Drops for Fuchs' Dystrophy (PHANTOM Trial)

Phase 2

Waitlist Available

Research Sponsored by Santen Inc.

Eligibility Criteria Checklist

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

Must have

Male or female diagnosed with FECD

Be older than 18 years old

Must not have

Females who are pregnant or lactating

History of any ocular surgery for FECD in the study eye (e.g., penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only (DSO))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 18 month

Awards & highlights

Summary

This trial is testing a new eye drop medication for people with a specific corneal dystrophy. The study will last 18 months and compare the new medication to a placebo.

Who is the study for?

This trial is for men and women diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). It's not open to pregnant or breastfeeding women, nor to those who have had certain eye surgeries like corneal transplants in the affected eye.Check my eligibility

What is being tested?

The study tests two strengths of STN1010904 ophthalmic suspension (0.03% and 0.1%), given twice daily against a placebo, over an 18-month period with nine visits, to see how well they work and their safety in treating FECD.See study design

What are the potential side effects?

While specific side effects are not listed here, typical ones from ophthalmic suspensions may include eye irritation, discomfort, redness, blurred vision, dry eyes or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with Fuchs' Endothelial Corneal Dystrophy (FECD).

Exclusion Criteria

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

Select...

I am not pregnant or breastfeeding.

Select...

I have had eye surgery for FECD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 18 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 18 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in BCVA with contrast level of 10% at Month 18

Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18

Change from baseline in contrast sensitivity with glare light at Month 18

Secondary outcome measures

BCVA with contrast level of 10% at all post-baseline visits

Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits

Contrast sensitivity with glare light at all post-baseline visits

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: STN1010904 ophthalmic suspension 0.1% BIDExperimental Treatment1 Intervention

Group II: STN1010904 ophthalmic suspension 0.03% BIDExperimental Treatment1 Intervention

Group III: Placebo Vehicle BIDPlacebo Group1 Intervention

0 / 3Eligibility 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' Endothelial Corneal Dystrophy (FECD) treatments primarily aim to improve the function of corneal endothelial cells, which are responsible for maintaining corneal transparency by regulating fluid balance. Common treatments include hypertonic saline drops to reduce corneal swelling, and in advanced cases, corneal transplantation to replace damaged endothelial cells. Emerging treatments like STN1010904 ophthalmic suspension potentially target and enhance the function of existing endothelial cells, thereby improving corneal clarity and delaying the need for surgical intervention. This is crucial for FECD patients as it offers a less invasive option to manage symptoms and maintain vision quality.

Effects of fluorouracil and fluorouridine on protein synthesis in rabbit retina.Effects of subconjunctival 5-fluorouracil injections on the corneal endothelium and ciliary epithelium.A comparison of 5-fluorouridine and 5-fluorouracil in an experimental model for the treatment of vitreoretinal scarring.