NGF Treatment for Patients With Neuropathic Corneal Pain

NCT05700864 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00002840
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single center, interventional, open-label, single arm, non-randomized trial seeks to investigate the efficacy of Oxervate® (cenergermin 0.002% eye drops) on ameliorating the signs and symptoms of neuropathic corneal pain (NCP). The study aims to enroll 28 subjects with NCP. All patients will be evaluated for clinical symptoms and signs of NCP, corneal staining and nerve regeneration (by IVCM) at Baseline (Visit 2) through the end of study (16 weeks post treatment).

Conditions

Corneal Disease; Neuropathy

Outcome Measures

Primary Outcomes (3)

• Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by corneal nerve regeneration.

  Quantifying total number of nerves of the corneal subbasal nerve plexus through in vivo confocal microscopy IVCM), summation of main trunk and branch nerves in one image reported as frame/nerve. Change from baseline in nerve quantity on IVCM at 16 weeks.

  From Baseline Visit to End of Study Visit (16 weeks post treatment)

• Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by changes in ocular inflammation on in vivo confocal microscopy

  Change in dendritic cell density on in vivo confocal microscopy from baseline to 16 weeks. The total nerve density will be assessed as the total nerve length in micrometers per image frame area (0.16mm\^2), from the three best representative images of each eye.

  From Baseline Visit to End of Study Visit (16 weeks post treatment)

• Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by changes in ocular redness using the McMonnies/Chapman-Davies (MC-D) grading scale.

  Changes in grade of conjunctival hyperemia and bulbar conjunctival redness using the McMonnies/Chapman-Davies (MC-D) scale 0-1-2-3-4-5, 0 being absent conjunctival redness and 5 being severe conjunctival hyperemia

  From Baseline Visit to End of Study Visit (16 weeks post treatment)

Secondary Outcomes (10)

• Occurrence of treatment-related adverse events assessed by severity and temporal relationship of study treatment.

  From Baseline Visit to End of Study Visit (16 weeks post treatment)

• Tolerability of OXERVATE 0.002% on neuropathic corneal pain as assessed by the ocular surface disease index (OSDI) questionnaire, change from baseline ocular symptom score on OSDI

  From Baseline Visit to End of Study Visit (16 weeks post treatment)

• Patient Reported outcome on quality of life dimensions of OXERVATE 0.002% on neuropathic corneal pain as assessed by Ocular Pain Assessment Survey (OPAS), change from baseline ocular pain score on OPAS

  From Baseline Visit to End of Study Visit (16 weeks post treatment)

• Changes in corneal nerve function as assessed by hyperosmolar eye-drop test, change from baseline pain score on the Visual Analog Scale (VAS) at 16 weeks.

  From Baseline Visit to End of Study Visit (16 weeks post treatment)

• Resolution of peripheral pain component as assessed by proparacaine eye-drop test, change from baseline pain score on the Visual Analog Scale (VAS) at 16 weeks.

  From Baseline Visit to End of Study Visit (16 weeks post treatment)

Study Arms (1)

Oxervate® (cenegermin)

EXPERIMENTAL

OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj

Drug: Cenegermin-Bkbj

Interventions

Cenegermin-Bkbj DRUG

Cenegermin-bkbj ophthalmic solution administered as one drop in both eyes every 3 hours 4 times daily for 4 weeks

Also known as: OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution

Oxervate® (cenegermin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥ 18 years
• Symptoms of neuropathic corneal pain at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.
• Positive ICVM findings
• If female with childbearing potential, have a negative pregnancy test
• Best corrected distance visual acuity, using corrective lenses if necessary, in the study eye of at least +1.0 Log MAR (Snellen \<20/200)
• Satisfying all Informed Consent requirements
• Ability and willingness to comply with study procedures
• Ability to speak and understand the English language sufficiently to understand the study, provide written consent, and allow completion of all study assessments

You may not qualify if:

• Evidence of any active ocular infection
• Evidence of any intraocular inflammation
• Evidence of any persistent epithelial defect/ulcer
• Evidence of any corneal scar/corneal edema
• Presence of any other ocular conditions that require topical medications
• History of severe systemic allergy or severe ocular allergy
• Inability to suspend topical medications during the duration of the study
• Inability to suspend oral medications for NCP.
• No changes in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX)
• History of any ocular surgery within three months before study Visit 1(day 0)
• Ocular surgery expected during the 16 weeks of the trial
• Use of refractive/therapeutic contact lenses during the study period
• Female patients that are pregnant/have a positive pregnancy test result/are breast-feeding/intend to become pregnant during the study treatment period
• Drug addiction/alcohol abuse within the last year
• Participation in another clinical trial

Sponsors & Collaborators

• Tufts Medical Center: lead
• Dompé Farmaceutici S.p.A: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Corneal Diseases

Interventions

cenegermin

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Pedram Hamrah, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: January 26, 2023
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)