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

Phase

N/A

Condition

Eye Disorders/infections

Treatment

Cenegemin in the DEFENDO Study

Clinical Study ID

NCT05552261

NGF0122

Ages > 18
All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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.

Study Design

Cenegemin in the DEFENDO Study

February 01, 2023

April 12, 2024

Study 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.

Connect with a study center

Gordon Schanzlin New Eye Institute
La Jolla, California 92037
United States
Site Not Available
Gordon Schanzlin New Eye Institute
San Diego, California 92122
United States
Site Not Available
New Vision Institute
San Diego 5391811, California 5332921 92037
United States
Site Not Available
Cincinnati Eye Institute
Edgewood, Kentucky 41017
United States
Site Not Available
Cincinnati Eye Institute
Edgewood 4290873, Kentucky 6254925 41017
United States
Site Not Available
Tufts Medical Center
Boston, Massachusetts 02011
United States
Site Not Available
Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02011
United States
Site Not Available
Scheie Eye Institute
Philadelphia, Pennsylvania 19104
United States
Site Not Available
Scheie Eye Institute
Philadelphia 4560349, Pennsylvania 6254927 19104
United States
Site Not Available

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