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

Dompé

Status: Completed

Conditions: Neurotrophic Keratitis

Treatments: Drug: Cenegemin in the DEFENDO Study

Study type: Observational

Funder types: Industry

Identifiers

NCT05552261

NGF0122

Details and patient eligibility

About

Primary Objective

To evaluate the long-term safety and efficacy (healing) of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in Stage 1 neurotrophic keratitis (NK) patients who enrolled in the DEFENDO study.

Secondary Objective

To evaluate the long-term efficacy of OXERVATE® 0.002% (20 mcg/mL) cenergemin-bkbj ophthalmic solution in terms of corneal sensitivity, Schirmer I test, tear film break-up time (TFBUT), best corrected distance visual acuity (BCDVA), and quality of life at 24 and 30 months post-treatment

Full description

NGF0122 (DEFENDO Long-Term Follow-up) study was a Phase 4, multicenter, open label, long-term follow-up study evaluating safety and efficacy in the patients with Stage 1 Neurotrophic Keratitis (NK) who were enrolled in the NGF0120 (original DEFENDO) study and were treated with OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution for up to 8 weeks in the NGF0120.

After completing enrollment in the NGF0120 Study, patients were invited to enter the NGF0122 Study (all standard of care permitted) in which two additional long-term follow-up visits occurred at 24- and 30-months post-treatment to evaluate long-term clinical outcomes.

In the NGF0122, study patients enrolled in the NFG0120 study were evaluated starting from week 8, which corresponds to the end of treatment of the NGF0120 study and is to be considered as the baseline of the NGF0122 study itself.

Patients were treated per standard of care including additional OXERVATE® 0.002% if deemed appropriate by the Investigator.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Previously enrolled in the DEFENDO Study.
2. Satisfied all Informed Consent requirements. The patient and/or their legal representative read, signed, and dated the IRB approved Informed Consent document before any study-related procedures were performed.
3. Had the ability and willingness to comply with study procedures.

Exclusion criteria

Were participating in another study that involved treating the study eye. Participation in non-ocular studies was acceptable provided that the treatment was not considered to be confounding with the DEFENDO Long-Term Follow-up Study, in the opinion of the Investigator.

Trial design

24 participants in 1 patient group

Group Long-term follow-up

Description:

All eligible patients, after completing enrollment in the original DEFENDO Study, were invited to enter the DEFENDO Long-Term Follow-Up Study (all standard of care permitted), according to inclusion and exclusion criteria.

Treatment:

Drug: Cenegemin in the DEFENDO Study