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DEFENDO Long-Term Follow-up Study

Title 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
Therapeutic Area Neurotrophic Keratitis
Principal Investigator Pedram Hamrah, MD
Min Age 18 Years
Gender Any
Contact Karaghan Curran


After completing enrollment in the original DEFENDO Study, patients will be invited to enter the DEFENDO Long-Term Follow-up Study (all standard of care is permitted). Two additional long-term follow-up visits will occur at 18- and 24-months to evaluate long-term clinical outcomes. No study treatment will be provided. Patients will be treated per standard of care as determined by the Investigator and will document topical ophthalmic medications currently being administered at time of study participation. 

Study Details

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

1. 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

Study Requirements

This study includes observational procedures after you have received OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in the DEFENDO study. Subjects will return to the eye center clinic for two additional long-term follow-up visits occurring at 18- and 24-month post-treatment to evaluate long-term clinical outcomes. All examinations and imaging procedures that will be performed during the research study are routinely performed; no experimental examinations or procedures are foreseen in this study.