Dompé Farmaceutici S.p.A
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.
Neurotrophic Keratitis
Cenegemin in the DEFENSE Study
This clinical study will be a multi-center, open label, long term follow-up study of the patients who were enrolled in the DEFENDO Study who had Stage 1 Neurotrophic Keratitis (NK) who were treated with OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution. The DEFENDO Long-Term Follow-up Study will have follow-up with the patients at month 24-30 post-treatment in the DEFENDO Study: All patients will be evaluated in a real-world setting post the enrollment in the DEFENDO Study through 30 months. Patients will be treated per standard of care as determined by the Investigator and will document topical ophthalmic medications. The original DEFENDO Study duration was for a total of 34 weeks: a screening period of 2 weeks, followed by enrollment in 8 weeks of OXERVATE™ treatment and an Off- Treatment Follow-Up of 6 months. 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 24- and 30-months to evaluate long-term clinical outcomes.}}
Study Type : | Observational |
Estimated Enrollment : | 37 participants |
Official 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 |
Actual Study Start Date : | December 20, 2022 |
Estimated Primary Completion Date : | September 4, 2024 |
Estimated Study Completion Date : | September 4, 2024 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Gordon Schanzlin New Eye Institute
La Jolla, California, United States, 92037
Recruiting
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
Not yet recruiting
Tufts Medical Center
Boston, Massachusetts, United States, 02011
Not yet recruiting
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104