DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group Long-term follow-up All eligible patients, after completing enrollment in the original DEFENDO Study, will be invited to enter the DEFENDO Long-Term Follow-Up Study (all standard of care is permitted), according to inclusion and exclusion criteria. |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Corneal Epithelial Healing [From baseline to 24 months]
Percentage of patients who have corneal epithelial healing at 24 months and 30 months of the long- term follow-up.
- Corneal Epithelial Healing [From baseline to 30 months]
Percentage of patients who have corneal epithelial healing at 24 months and 30 months of the long- term follow-up.
Secondary Outcome Measures
- Corneal Sensitivity [24 months and 30 months]
Percentage of patients who achieved an improvement in corneal sensitivity at 24 months and 30 months of the long-term follow-up.
- Change from Baseline in BCDVA at 24 months and 30 months [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.
- Change from Baseline in TFBUT at 24 months and 30 months [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.
- Percentage of patients that achieve a 15- letter gain in BCDVA [24 months and 30 months]
Best Corrected Distance Visual Acuity (BCDVA)
- Change from baseline in Quality of life (QoL) change from baseline [24 months and 30 months]
EQ-5D-5L questionnaire will be completed by participants
- Change from baseline in Quality of life (QoL) change from baseline [24 months and 30 months]
IDEEL questionnaire will be completed by participants
- Change from baseline in corneal nerve structure (IVCM) at months 24 and 30 [24 months and 30 months]
Change from the Baseline Visit in the DEFENDO Study in corneal nerve structure with confocal microscopy
- Change from baseline in Optical Coherence Tomography (OCT) at months 24 and 30 [24 months and 30 months]
Evaluate the change from the Baseline Visit in the DEFENDO Study in epithelial thickness with anterior-segment OCT
Eligibility Criteria
Criteria
Inclusion Criteria:
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Previously enrolled in the DEFENDO Study.
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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.
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Must have the ability and willingness to comply with study procedures.
Exclusion Criteria:
Participating in another study that involves treating the study eye.
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gordon Schanzlin New Eye Institute | San Diego | California | United States | 92122 |
| 2 | Tufts Medical Center | Boston | Massachusetts | United States | 02011 |
| 3 | Scheie Eye Institute | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Dompé Farmaceutici S.p.A
Investigators
- Study Chair: Flavio Mantelli, MD, PhD, Dompé
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NGF0122