NCT06048380 The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
| NCT ID | NCT06048380 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Singapore Eye Research Institute |
| Condition | Fuchs' Endothelial Dystrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2025-03-01 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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 that interferes with normal vision). 2. Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied. 3. Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures. 4. Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery. Exclusion Criteria: 1. Patients who are unable to give consent. 2. An only-functioning eye in a patient who has lost visual potential in the contralateral eye. 3. Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study. 4. History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease. 5. Patients who have previous allergic reactions to the contents present in Glanatec Ophthalmic solution 0.4%
Contact & Investigator
Marcus Ang
PRINCIPAL INVESTIGATOR
Singapore Eye Research Institute
Frequently Asked Questions
Who can join the NCT06048380 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 100 Years, studying Fuchs' Endothelial Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06048380 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT06048380 currently recruiting?
Yes, NCT06048380 is actively recruiting participants. Contact the research team at Marcus.Ang@Singhealth.com.sg for enrollment information.
Where is the NCT06048380 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06048380 clinical trial?
NCT06048380 is sponsored by Singapore Eye Research Institute. The principal investigator is Marcus Ang at Singapore Eye Research Institute. The trial plans to enroll 120 participants.