Fuchs' Endothelial DystrophyPhase 3NCT06048380
The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
A Phase 3 study testing Ripasudil in people with Fuchs' Endothelial Dystrophy and Cataract, run by Singapore Eye Research Institute at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Fuchs' Endothelial Dystrophy, Cataract
- What is being tested?
- Ripasudil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2025to Jul 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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.
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore National Eye Centre
Singapore, Singapore, 168751
Marcus Ang, +65 62277255, Marcus.Ang@Singhealth.com.sg
Marcus Ang
About this study
Official title: The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
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.
Read the detailed description
Patients with Fuch's Corneal Endothelial Dystrophy and undergoing femtosecond laser-assisted cataract surgery will be recruited for this study. They will be randomly assigned into treatment or placebo group.
The investigators hypothesize that the ROCK inhibitor ripasudil 0.4% helps maintain corneal endothelial functional integrity and reduce cell loss after cataract surgery in patients with FED.
To test the hypothesis, the investigators plan to conduct a randomized clinical trial which aims to:
- Evaluate the clinical outcomes of FED eyes following FLACS with and without ripasudil 0.4%
- To identity which FED patients will most likely benefit from the use of ripasudil 0.4% based on pre-operative parameters
- To monitor for any adverse effects in patients assigned to ripasudil 0.4%
- Conditions
- Fuchs' Endothelial Dystrophy, Cataract
- Being tested
- Ripasudil, Placebo
- Keywords
- Ripasudil
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RipasudilDrug
Also called Glanatec
Glanatec Ophthalmic Solution 0.4% W/V with ripasudil hydrochloride hydrate as active ingredient is currently being used by patients with ocular hypertension or open-angle glaucoma.
Inhibition of Rho kinase to facilitate aqueous outflow from the conventional outflow pathway via the trabecular meshwork and Schlemm's canal has been suggested as the IOP-lowering mechanism of action by ripasudil.
PlaceboOther
Saline eye drops
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants in this group will be asked to instill Glanatec Ophthalmic Solution (containing Ripasadil 0.4%) 4 times a day for 1 month following cataract removal surgery. Receives: Drug: Ripasudil |
| Placebo | Placebo comparator | Participants in this group will be asked to instill saline solution 4 times a day for 1 month following cataract removal surgery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
The ECD at 15 different locations of the cornea is measured with a widefield specular microscope.
This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.
Measured: 3 months
Secondary outcomes (1)
To monitor for conjunctival hyperemia in participants in treatment group.
The Cornea and Contact Lens Research Unit (CCLRU) grading scale will be used as an objective assessment guideline for grading conjunctival hyperaemia.
The investigators will grade the conjunctival hyperemia This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Mar 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Ang Han Nian, Singapore Eye Research Institute
- Investigators
- Marcus Ang, Principal investigator, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048380
- Sponsor's protocol ID
- R1958/01/2023
- Status last verified
- Jan 2025
- First submitted
- 26 Jun 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT06048380
- Acronym / sponsor ID
- R1958/01/2023
- Conditions
- Fuchs' Endothelial Dystrophy, Cataract
- Keywords
- Ripasudil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with Fuch's Corneal Endothelial Dystrophy and undergoing femtosecond laser-assisted cataract surgery will be recruited for this study. They will be randomly assigned into treatment or placebo group.
The investigators hypothesize that the ROCK inhibitor ripasudil 0.4% helps maintain corneal endothelial functional integrity and reduce cell loss after cataract surgery in patients with FED.
To test the hypothesis, the investigators plan to conduct a randomized clinical trial which aims to:
- Evaluate the clinical outcomes of FED eyes following FLACS with and without ripasudil 0.4%
- To identity which FED patients will most likely benefit from the use of ripasudil 0.4% based on pre-operative parameters
- To monitor for any adverse effects in patients assigned to ripasudil 0.4%
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: RipasudilParticipants in this group will be asked to instill Glanatec Ophthalmic Solution (containing Ripasadil 0.4%) 4 times a day for 1 month following cataract removal surgery. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this group will be asked to instill saline solution 4 times a day for 1 month following cataract removal surgery. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
- 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.
Key exclusion criteria (5 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RipasudilAlso: GlanatecGlanatec Ophthalmic Solution 0.4% W/V with ripasudil hydrochloride hydrate as active ingredient is currently being used by patients with ocular hypertension or open-angle glaucoma. Inhibition of Rho kinase to facilitate aqueous outflow from the conventional outflow pathway via the trabecular meshwork and Schlemm's canal has been suggested as the IOP-lowering mechanism of action by ripasudil. | Drug | Treatment |
| PlaceboSaline eye drops | Other | Placebo |
Primary outcome
Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
Time frame: 3 months
The ECD at 15 different locations of the cornea is measured with a widefield specular microscope. This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.
1 secondary outcome
To monitor for conjunctival hyperemia in participants in treatment group.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcus Ang principal investigator
Singapore Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ripasudil in people with Fuchs' Endothelial Dystrophy and Cataract, run by Singapore Eye Research Institute at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus Ang (+65 62277255, Marcus.Ang@Singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.