NCT06411145

Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis

A Prospective, Multicenter Trial to Evaluate Efficacy and Safety of Cenegermin-bkbj (20 mcg/mL) Ophthalmic Solution on Corneal Thickness Via Anterior Segment Optical Coherence Tomography (AS-OCT) in Stage 3 Neurotrophic Keratitis

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To assess the efficacy of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on overall corneal thickness via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16. Secondary Objectives: To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal stromal thickness via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16. To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal stromal reflectivity via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16. To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal sensitivity via Cochet-Bonnet aesthesiometer in the center of the lesion with respect to change from baseline at weeks 4, 8, and 16.

Detailed description

This clinical study is a prospective, open-label, interventional, multicenter study of 8 weeks of treatment with 8 weeks of follow-up after treatment to evaluate the efficacy of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal thickness and stromal clarity via AS-OCT in patients with stage 3 neurotrophic keratitis. The study will be a total of 16 weeks in duration: an optional screening period of up to 2 weeks, followed by an 8-week treatment period and an 8-week follow-up period. At Visit 1.2 (Baseline and Study Product Dispense, Day -1), patients meeting the entry criteria for this study will be assigned to treatment with cenegermin-bkbj (20 mcg/mL) ophthalmic solution (which will be known as Study Product) beginning the morning following that visit, or Day 0. After completion of the Treatment Period, all patients who do not meet deterioration or no improvement criteria will continue to be followed for an additional 8-week Follow-Up Period. At any time during the study, patients may be seen for additional unscheduled visits as deemed necessary by the Investigator. For patients who are prematurely discontinued from the study at any point, an exit examination should be completed which represents the next data collection visit in the study timeline. Once exited, the Investigator should direct patients for further treatment as appropriate. Patients in this study who are prematurely discontinued before completion of 8 weeks of treatment with cenegermin-bkbj (20 mcg/mL) ophthalmic solution will continue to be followed throughout the remainder of the study period, if able. To minimize risk of bias, all images will be assessed at an independent central reading center (CRC). The study site will acquire the images and perform a quality check; however, no analysis is required to be conducted by the Investigator on site. Visits list: 1. Visit 1.1- Screening Visit (Day -14 to -1) 2. Visit 1.2- Baseline Visit and Study Product Dispensation (Day -1) 3. Treatment Period (Weeks 1-8) 4. Visit 2- Study Product Dispensation (Day 14 ± 3 days) 5. Visit 3- Mid-Treatment Week 4 Evaluation and Study Product Dispensation(Day 28 ± 3 days) 6. Visit 4- Study Product Dispensation Visit (Day 42 ± 3 days) 7. Visit 5- End-of-Treatment Week 8 Evaluation (Day 56 ± 3 days) 8. Follow-Up Period (Weeks 9-16) 9. Visit 6- Final Follow-Up Week 16 Evaluation (Day 112 ± 3 days)

Conditions

• Neurotrophic Keratitis
• Neurotrophic Keratopathy
• Corneal Ulcer

Interventions

Type	Name	Description
DRUG	OXERVATE® 0.002%	Cenegermin-bkbj (20 mcg/mL) is an ophthalmic solution contained in a multiple-dose vial. The topical drops are administered 6 times/day for a 8-week course.

Timeline

• Start date: 2024-04-26
• Primary completion: 2024-11-12
• Completion: 2024-11-12
• First posted: 2024-05-13
• Last updated: 2024-12-02

Regulatory

• FDA-regulated drug study