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

Last updated: September 18, 2024
Sponsor: Dompé Farmaceutici S.p.A
Overall Status: Completed

Phase

N/A

Condition

Eye Disorders/infections

Treatment

Cenegemin in the DEFENDO Study

Clinical Study ID

NCT05552261
NGF0122
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Previously enrolled in the DEFENDO Study.

  2. Satisfy all Informed Consent requirements. The patient and/or his/her legalrepresentative has read, signed, and dated the IRB approved Informed Consentdocument before any study-related procedures are performed.

  3. Must have the ability and willingness to comply with study procedures.

Exclusion

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.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Cenegemin in the DEFENDO Study
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
April 12, 2024

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.

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

  • Cincinnati Eye Institute

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02011
    United States

    Site Not Available

  • Scheie Eye Institute

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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