Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients
- Conditions
- eurotrophic KeratitisMedDRA version: 20.0Level: PTClassification code 10069732Term: Neurotrophic keratopathySystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2019-002475-34-DE
- Lead Sponsor
- Recordati Rare Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 108
1. Be a male or female aged = 18 years
2. Have Stage 2 moderate (PED) or Stage 3 severe (corneal ulcer) NK involving only 1 eye (study eye) and of at least 2 weeks duration.
3. Have no objective clinical evidence of improvement in the PED or corneal ulceration within the 2 weeks before the Screening Visit despite use of conventional non-surgical treatment.
4. Have decreased corneal sensitivity (= 4 cm using the Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant.
5. Have a BCDVA score = 75 ETDRS letters in the study eye, due to NK.
Refer to the exhaustive list of inclusion criteria in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
Individuals meeting any of the following criteria at the Screening Visit are ineligible to participate in this study.
For the study eye:
1. Have severe blepharitis and/or severe meibomian gland disease in the study eye.
2. Have severe vision loss in the study eye with no potential for visual improvement in the opinion of the investigator as a result of the study treatment.
3. Have evidence of corneal ulceration/melting involving the posterior third of the corneal stroma, or perforation in the study eye.
4. Have a history of corneal transplantation in the study eye, performed less than 12 months prior screening.
5. Have had prior surgical procedures for the treatment of NK (eg,
complete tarsorrhaphy, conjunctival flap, etc.) except partial
tarsorrhaphy if done more than 6 months prior to screening visit (with investigators assessment documenting that the eye lids are functioning sufficiently to ensure adequate protection of the eye) and amniotic membrane transplantation, if at least 2 weeks after the membrane has disappeared within the area of the PED or corneal ulcer (and at least 6 weeks after the procedure) in the study eye.
Patients previously treated with Botox® (Botulinum toxin) injections
used to induce pharmacologic blepharoptosis are eligible for enrolment only if the last injection was given at least 3 months before the Screening Visit.
6. Have an uncontrolled glaucoma at the Screening Visit
7. Have Stage 2 or 3 NK or perforation (for the fellow eye).
8. Have had prior treatment with Oxervate (cenegermin eye drops).
Refer to the exhaustive list of exclusion criteria in the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • In the first 24 patients, to determine the safety, tolerability and PK profile of REC 0/0559 (MT8) given as 1 drop 4 times a day (QID) of escalating doses up to 50 µg/mL.<br>• To determine the efficacy and safety of MT8 given as 1 drop QID at 5, 25, and 50 µg/mL during 8 weeks and select the dose with the best benefit risk ratio.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of this study is the percentage of patients achieving complete corneal healing of persistent epithelial defects (PED) or corneal ulcer at Week 8, defined as no corneal fluorescein staining in the area of the PED or corneal ulcer as assessed by an independent central reading centre.;Timepoint(s) of evaluation of this end point: week 8
- Secondary Outcome Measures
Name Time Method