The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery

NCT06048380 | Recruiting Phase 3

• 1 other identifier: R1958/01/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Keywords

Ripasudil

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• To monitor for conjunctival hyperemia in participants in treatment group.

  3 months

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Ripasudil DRUG

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.

Also known as: Glanatec

Treatment

Placebo OTHER

Saline eye drops

Placebo

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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%

Sponsors & Collaborators

• Singapore Eye Research Institute: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore, 168751, Singapore

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Interventions

K-115

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lens Diseases

Study Officials

• Marcus Ang

  Singapore Eye Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Ang

CONTACT

+65 62277255; Marcus.Ang@Singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Professor

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: September 21, 2023
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)