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Clinical trial

A Long-term Extension Study to Evaluate the Safety and Efficacy of OXERVATE 0.002% (20 mcg/mL) Cenegermin-bkbj Ophthalmic Solution in Patients With Stage 1 Neurotrophic Keratitis Who Enrolled in the DEFENDO Study

ID
Name
NGF0122
Description
The primary objectives are to evaluate the long-term safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in Stage 1 Neurotrophic Keratitis (NK) patients who enrolled in the DEFENDO Study.
Trial arms
Trial start
2022-12-20
Estimated PCD
2024-09-04
Trial end
2024-09-04
Status
Recruiting
Treatment
Cenegemin in the DEFENDO Study
Cenegemin as administered in the DEFENDO Study. Long-term safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered in Stage 1 Neurotrophic Keratitis (NK) patients enrolled in the DEFENDO Study (NCT number NCT04485546). No intervention was performed in this follow-up / extension trial.
Arms:
Group Long-term follow-up
Other names:
OXERVATE™
Size
37
Primary endpoint
Corneal Epithelial Healing
From baseline to 24 months
Corneal Epithelial Healing
From baseline to 30 months
Eligibility criteria
Inclusion Criteria: 1. Previously enrolled in the DEFENDO Study. 2. Satisfy all Informed Consent requirements. The patient and/or his/her legal representative has read, signed, and dated the IRB approved Informed Consent document before any study-related procedures are performed. 3. Must have the ability and willingness to comply with study procedures. Exclusion Criteria: Participating in another study that involves treating the study eye. a. Participation in non-ocular studies is acceptable provided that the treatment is not considered to be confounding with the DEFENDO Long-Term Follow-up Study, in the opinion of the Investigator.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 37, 'type': 'ESTIMATED'}}
Updated at
2023-03-15

1 organization

1 product

1 indication

Organization
Dompé Farmaceutici
Product
Cenegemin
Indication
Neurotrophic Keratopathy