PXL-Platinum 330 in Eyes With Corneal Thinning Conditions

NCT05489510 | Withdrawn Phase 1 FDA Drug FDA Device

• 1 other identifier: STUDY21040139
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 system for performing corneal collagen cross-linking (CXL) for the treatment of corneal thinning disorders. The PXL Platinum 330 system is a combination product consisting of a UVA 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke-TE 0.25% ophthalmic solution or Peschke-L 0.23% ophthalmic solution) administered in conjunction with the UVA light as a photosensitizer.

Conditions

Corneal Thinning; Keratoconus

Outcome Measures

Primary Outcomes (1)

• PXL-Platinum 330 system

  Keratometry

  12 months

Other Outcomes (1)

• Efficacy measurements by best spectacle-corrected visual acuity

  12 months

Study Arms (2)

Pulsed lighting

OTHER

Combination Product: Pulsed or continuous lighting

Continuous lighting

OTHER

Combination Product: Pulsed or continuous lighting

Interventions

Pulsed or continuous lighting COMBINATION_PRODUCT

The cross-linking procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UVA light source and riboflavin solution).

Continuous lighting; Pulsed lighting

Eligibility Criteria

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

You may qualify if:

• years of age or older.
• Presence of central or inferior steepening.
• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration.
• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as: a. Fleischer ring b. Vogt's striae c. Decentered corneal apex d. Munson's sign e. Rizzutti's sign f. Apical Corneal scarring consistent with Bowman's breaks g. Scissoring of the retinoscopic reflex h. Crab-claw appearance on topography
• Steepest keratometry (Kmax) value ≥ 47.20 D.
• I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map.
• Posterior corneal elevation \>16 microns.
• Thinnest corneal point \<485 microns.
• Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eye.s 10. Bacterial or fungal corneal keratitis persistent and not responding despite \> 2 weeks of standard antimicrobial therapy or with rapid. progression of corneal thinning, with loss of \>25% corneal thickness
• Contact Lens Wearers Only: a. Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid gas permeable 2 Weeks per decade of wear
• Signed written informed consent.
• Willingness and ability to comply with schedule for follow-up.

You may not qualify if:

• Eyes classified as either normal or atypical normal on the severity grading scheme.
• Corneal pachymetry at the screening exam that is \<300 microns at the thinnest point in the eye(s) to be treated.
• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
• History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
• Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
• Pregnancy (including plan to become pregnant) or lactation during the course of the study.
• A known sensitivity to study medications.
• Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
• Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.

Sponsors & Collaborators

• Vishal Jhanji: lead

Study Sites (1)

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Vishal Jhanji, MD

  UPMC Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Subjects will be assigned randomly to either pulsed or continuous lighting.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: Prospective, double-arm, randomized single-site study

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: August 5, 2022
• Study Start: August 15, 2023
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: An indefinite period.
• Access Criteria: Deidentified individual participant data sets with other researchers outside of your study team.

Locations

US (1)