Moderate to advanced Fuchs endothalial corneal dystrophy (FECD) MedDRA version: 20.1 Level: LLT Classification code 10062973 Term: Fuchs' endothelial dystrophy System Organ Class: 100000004850
Conditions
Interventions
Trade Name: Glanatec Ophthalmic Solution 0.4%
Pharmaceutical Form: Eye drops
Pharmaceutical form of the placebo: Eye drops
Route of administration of the placebo: Ophthalmic use (Noncurrent)
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained from the subject 2. Understanding of study procedures and willingness to abide by all procedures during the course of the study. 3. Age range: 18-95 years 4. Diagnosis of moderate to advanced FECD with central guttae and clinical relevant corneal endothelial cell loss of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinical signs or suspicion of an acute infection 2. Acute ophthalmic infection (bacterial, viral or fungal) 3. Any known ophthalmic disease other than FECD and/or cataract 4. Known contra-indications for ripasudil or comparator 5. Use of soft lenses 6. Known severe comorbidities which may interfere with an ophthalmic surgical procedure at the discretion of the investigator 7. Use of any inadmissible medication, e.g. glucocorticoids (any systemic administration; if topically administered any glucocorticoid eye drops to be administered >2 times per day) 8. Nursing mother or pregnant woman, as verified by a positive pregnancy test. 9. Known hypersensitivity to the IMPs (ripasudil or comparator), or any of their formulation ingredients. 10. Treatment of dry eyes, such as artificial tears or hygienic eye lid cleaning 11. Known hypersensitivity to concomitant ophthalmic medication (e.g. antibiotic eye drops or glucocorticoid-containing eye drops) 12. Subject who is imprisoned or is lawfully kept in an institution. 13. Employee or direct relative of an employee of the study site or the sponsor 14. Participation in an interventional clinical study with an IMP within the last 4 weeks 15. Previous participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of ripasudil 0.4% eye drops administered 3 times daily for up to 3 months after descemetorhexis in patients with moderate to advanced FECD compared to placebo;Primary end point(s): The primary safety endpoint is defined as the incidence of AR and SAR within the observation period of 3 months after descemetorhexis;Timepoint(s) of evaluation of this end point: 3 months after start of intervention;Secondary Objective: •To assess the rate of AE, AR, SAE, SAR and SUSAR within the observation period of 6 months after descemetorhexis •To assess the effect of ripasudil on corneal endothelial cell density (ECD) within the period of 6 months after descemetorhexis •To assess the effect of ripasudil on corneal thickness within the period of 6 months after descemetorhexis •To assess the effect of ripasudil on visual acuity (BCVA) within the period of 6 months after descemetorhexis •To assess the effect of ripasudil on contrast sensitivity within the period of 6 months after descemetorhexis •To assess the need of rescue therapy (DMEK) during the observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Resolution of corneal edema within the observation period of 6 months after descemetorhexis - Reestablishment of a continuous endothelial cell layer within the observation period of 6 months after descemetorhexis - Improvement of BCVA, defined as improvement of at least of two lines of BCVA related to the individual preoperative value within the observation period of 6 months after descemetorhexis - Improvement of contrast sensitivity, defined as improvement of at least two lines in Mars Charts) related to the individual preoperative value within the observation period of 6 months after descemetorhexis ;Timepoint(s) of evaluation of this end point: 6 months after start of intervention | — |
Countries
Germany
Contacts
Public ContactAugenklinik
Universitätsklinikum Erlangen
Outcome results
None listed