Thinking of joining a study?

Register your interest

NCT05552261 | Recruiting | Neurotrophic Keratitis


DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
Sponsor:

Dompé Farmaceutici S.p.A

Brief Summary:

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.

Condition or disease

Neurotrophic Keratitis

Intervention/treatment

Cenegemin in the DEFENSE Study

Detailed Description:

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
Criteria
Inclusion Criteria
  • Previously enrolled in the DEFENDO Study.
  • 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.
  • 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.

DEFENDO Long Term Follow-up Study in Stage 1 NK Patients

Location Details


Please Choose a site



DEFENDO Long Term Follow-up Study in Stage 1 NK Patients

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, California

Gordon Schanzlin New Eye Institute

La Jolla, California, United States, 92037

Recruiting

United States, Kentucky

Cincinnati Eye Institute

Edgewood, Kentucky, United States, 41017

Not yet recruiting

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02011

Not yet recruiting

United States, Pennsylvania

Scheie Eye Institute

Philadelphia, Pennsylvania, United States, 19104

Loading...