Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy

Launched by MARIAN MACSAI, MD · Aug 10, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called Glanatec® can help patients with Fuchs' Endothelial Dystrophy (FED) after they undergo a specific eye procedure known as descemet stripping, without needing a corneal transplant. Fuchs' Endothelial Dystrophy is an eye condition that can cause vision problems due to damage to the corneal cells. Although Glanatec® is already approved for treating glaucoma in Japan, the goal of this study is to see if it can effectively clear corneal cells and improve vision for patients who are not responding well to other treatments.

To be eligible for this trial, participants should be between 30 and 90 years old, have a diagnosis of Fuchs' dystrophy, and have certain visual symptoms that make them dissatisfied with their current vision. Participants will need to use eye drops as part of the study and attend regular follow-up appointments. This trial is currently recruiting and aims to provide more evidence about the safety and effectiveness of Glanatec® for improving vision in patients with this condition who may otherwise need a corneal transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Ability to understand read and sign the informed consent form.
• • Age between 30 and \<91 years
• • Ability to understand and follow instructions and study procedures
• • Willingness to comply with all study procedures and be available for the duration of the study
• • Ability to apply eye drop medication and willing to adhere to study medication regimen
• • Diagnosed with Fuchs dystrophy (clinically and on confocal microscopy) by the study investigator.
• • Pseudophakic FED with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
• • Fuchs dystrophy grades 2-4 on the Krachmer grading scale
• • Presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema
• • Clear peripheral cornea with an endothelial cell count \>1000 cells/mm2 on specular microscopy
• • Best corrected visual acuity in the study eye is 20/40 or worse at study enrollment
• • The patient is dissatisfied with current vision
• • The patient is otherwise to be offered a corneal graft
• • For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).
• • Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation
• Exclusion Criteria:
• • • Uncontrolled glaucoma (IOP \>25 mmHg)
• • Presence of secondary corneal pathology such as infective or autoimmune keratitis
• • Advanced corneal stromal edema defined as the presence of haze, bullae, or DM folds on slit-lamp biomicroscopy
• • History of herpes simplex virus or cytomegalovirus keratitis
• • Prior endothelial keratoplasty
• • Aphakic in study eye.
• • Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study
• • For women of child-bearing potential: Pregnant or lactating, or planning to become pregnant within the next 6 months.
• • Any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.