N/A N=24

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

Neurotrophic Keratitis

Bottom Line

View on ClinicalTrials.gov: NCT05552261 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Nov 2025

Primary outcome: Primary: Number/Percentage of Patients Who Achieved Corneal Epithelial Healing at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) and Remained Healed at Month 24 and Month 30 of the NGF0122 Study — 22; 14; 16 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Cenegemin in the DEFENDO Study (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dompé Farmaceutici S.p.A
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number/Percentage of Patients Who Achieved Corneal Epithelial Healing at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) and Remained Healed at Month 24 and Month 30 of the NGF0122 Study	22; 14; 16	—
PRIMARY Number/Percentage of Patients Who Did Not Achieve Corneal Epithelial Healing at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) Who Had a Healed Corneal Epithelium at Month 24 and 30 of the NGF0122 Study.	2; 2; 1	—
SECONDARY Number/Percentage of Patients With an Improvement in Corneal Sensitivity at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) Who Still Had Improvement in Corneal Sensitivity at Month 24 and 30 of the NGF0122 Study.	22; 11; 14	—
SECONDARY Number/Percentage of Patients Who Did Not Improved Corneal Sensitivity at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) and Improved Corneal Sensitivity at Month 24 and 30 of the NGF0122 Study.	2; 1; 0	—
SECONDARY Mean Change in Corneal Sensitivity From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) to Month 24 and Month 30 of the NGF0122 Study.	1.03; -0.69; 1.21; -0.63	—
SECONDARY Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) in Schirmer I Scores to Month 24 and Month 30 of the NGF0122 Study.	-2.8; -4.9; -0.8; -3.1	0.5158
SECONDARY Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) in TFBUT to Months 24 and 30 of the NGF0122.	0.695; 0.539; -0.384; -0.561	0.2836
SECONDARY Number/Percentage of Patients Who Achieved a 15-letter Improvement in BCDVA From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) to Month 24 and Month 30 of the NGF0122 Study.	2; 1; 0; 0	—
SECONDARY Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) to Month 24 and Month 30 of the NGF0122 Study.	-0.023; 0.124; -0.056; 0.087	0.7450
SECONDARY Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120 = Baseline NGF0122) in Quality of Life (QoL) Expressed by the IDEEL to Months 24 and 30 of the NGF0122 Study.	-0.32; 0.63; 1.83; 1.83; 14.50; 5.30	—
SECONDARY Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) in Quality of Life Measured With EuroQol 5-Dimension 5-Level (EQ-5D-5L) to Months 24 and 30 of the NGF0122 Study.	-0.1; -0.1; 0.1; 0.0; 0.0; -0.1	—
SECONDARY Number/Percentage of Subjects Reporting Adverse Events (AEs)	20; 4; 2; 18; 5; 12	—
SECONDARY Frequency of Normal and Clinically Significant Abnormal Findings for Slit-lamp Examination Parameters in the Study Eye at Baseline and Week 8 of the NGF0120 and at Month 24 and 30 of the NGF0122	22; 0; 22; 0; 15; 3	—

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 Criteria

Previously enrolled in the DEFENDO Study.
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.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05552261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.