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

Neurotrophic Keratitis Clinical Trial

— DEFENDO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552261
• Other study ID #: NGF0122
• Status: Recruiting
• Start date: December 20, 2022
• Est. completion date: September 4, 2024

Study information

• Verified date: February 2023
• Source: Dompé Farmaceutici S.p.A
• Contact: Sarah Wilting, MS
• Phone: 1-833-366-7387
• Email: usmedinfo[@]dompe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: September 4, 2024
• Est. primary completion date: September 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Previously enrolled in the DEFENDO Study.

2. 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.

3. 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.

Related Conditions & MeSH terms

• Keratitis
• Neurotrophic Keratitis

Intervention

Drug:
• Cenegemin in the DEFENDO Study
Cenegemin as administered in the DEFENDO Study. Long-term safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered in Stage 1 Neurotrophic Keratitis (NK) patients enrolled in the DEFENDO Study (NCT number NCT04485546). No intervention was performed in this follow-up / extension trial.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	Gordon Schanzlin New Eye Institute	La Jolla	California
United States	Scheie Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Dompé Farmaceutici S.p.A

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Epithelial Healing	Percentage of patients who have corneal epithelial healing at 24 months and 30 months of the long- term follow-up.	From baseline to 24 months
Primary	Corneal Epithelial Healing	Percentage of patients who have corneal epithelial healing at 24 months and 30 months of the long- term follow-up.	From baseline to 30 months
Secondary	Corneal Sensitivity	Percentage of patients who achieved an improvement in corneal sensitivity at 24 months and 30 months of the long-term follow-up.	24 months and 30 months
Secondary	Change from Baseline in BCDVA at 24 months and 30 months	Change from Baseline Visit in the DEFENDO Study in Best Corrected Distance Visual Acuity (BCDVA) at 24 months and 30 months of the long-term follow-up.	24 months and 30 months
Secondary	Change from Baseline in TFBUT at 24 months and 30 months	Change from the Baseline Visit in the DEFENDO Study in Tear Film Break Up Time (TFBUT) at 24 months and 30 months of the long-term follow-up.	24 months and 30 months
Secondary	Percentage of patients that achieve a 15- letter gain in BCDVA	Best Corrected Distance Visual Acuity (BCDVA)	24 months and 30 months
Secondary	Change from baseline in Quality of life (QoL) change from baseline	EQ-5D-5L questionnaire will be completed by participants	24 months and 30 months
Secondary	Change from baseline in Quality of life (QoL) change from baseline	IDEEL questionnaire will be completed by participants	24 months and 30 months
Secondary	Change from baseline in corneal nerve structure (IVCM) at months 24 and 30	Change from the Baseline Visit in the DEFENDO Study in corneal nerve structure with confocal microscopy	24 months and 30 months
Secondary	Change from baseline in Optical Coherence Tomography (OCT) at months 24 and 30	Evaluate the change from the Baseline Visit in the DEFENDO Study in epithelial thickness with anterior-segment OCT	24 months and 30 months