New treatment option for Fuchs' Endothelial Dystrophy
Official title The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
ClinicalTrials.gov ID: NCT06048380
What this study is testing
What is Ripasudil?
Ripasudil is an investigational medicine, being studied as a potential treatment for fuchs' endothelial dystrophy.
Also referred to as Glanatec.
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
- The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery. The secondary aim is to identity the characteristics of patients who will benefit the most with the use of ripasudil based on the test results obtained from this study.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 100
You may be able to join if
- Patients with FED who will be listed for cataract surgery as part of standard clinical practice (A cataract will be defined as clouding of the lens...
- Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
- Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
- Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery.
You likely can't join if
- Patients who are unable to give consent.
- An only-functioning eye in a patient who has lost visual potential in the contralateral eye.
- Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study.
- History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease.
- Patients who have previous allergic reactions to the contents present in Glanatec Ophthalmic solution 0.4%
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore, Singapore
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, 50 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore, Singapore. 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.