BridgeMD
New treatment option for Fuchs
Official title Descemet Endothelial Thickness Comparison Trial II
ClinicalTrials.gov ID: NCT05275972
What this study is testing
What is Ripasudil?
Ripasudil is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for fuchs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Sacramento, California, United States
- Palm Beach Gardens, Florida, United States
- Lebanon, New Hampshire, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Sacramento, California, United States; Palm Beach Gardens, Florida, United States; Lebanon, New Hampshire, United States; Portland, Oregon, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.