Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05833737
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-27
First Post:
2023-04-11
Brief Title:
Corneal Findings in Patients Treated With Belantamab Mafodotin
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Corneal Findings in Patients Treated With Belantamab Mafodotin - a Prospective Study Focusing on Corneal Nerves
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the upcoming years more and more ophthalmologists will be confronted with patients receiving Belantamab mafodotin Belamaf treatment due to the promising effects on survival in multiple myeloma patients Early at best subclinical detection of corneal damage may contribute to the definition of the optimal dosing regimen as well as therapy interval in each patient without the need to stop this lifesaving treatment However until today studies focusing on the development morphology and evolution of corneal epithelial changes associated with Belamaf treatment are scarce In order to clarify the precise pathomechanism of the associated keratopathy innovative imaging techniques such as corneal confocal microscopy CCM need to be used to follow patients prior to therapy and on a regular basis during treatment intervals In specific different regions of the cornea including the central apex the mid- periphery and the limbus need to be explored The latter in specific is often claimed to play an important role in the uptake of Belamaf into the cornea but has not been studied in any approach so far
Likewise there are no reports on the effects of Belamaf on corneal layers adjacent to the corneal epithelium in specific the subepithelial nerve plexus SNP Changes in this layer may suggest a potential peripheral neurotoxicneurodegenerative effect associated with Belamaf
Furthermore there is a lack of evidence from literature on how changes in the anterior layers of the cornea as studied with confocal microscopy in patients on Belamaf treatment differ from distinct corneal changes in these same layers in patients with other anterior corneal diseases including keratokonjunctivits sicca epithelium basement membrane dystrophy and limbal stem cell disease
At last regeneration of the corneal surface after Belamaf discontinuation has been described and is expected but detailed information on the time to corneal rehabilitation as well as confocal microscopic follow-up of epithelial and neuronal layers during this time is warranted The purpose of this monocentric prospective longitudinal study is to answer these specific research questions in a combined clinical approach using corneal confocal microscopy
Likewise there are no reports on the effects of Belamaf on corneal layers adjacent to the corneal epithelium in specific the subepithelial nerve plexus SNP Changes in this layer may suggest a potential peripheral neurotoxicneurodegenerative effect associated with Belamaf
Furthermore there is a lack of evidence from literature on how changes in the anterior layers of the cornea as studied with confocal microscopy in patients on Belamaf treatment differ from distinct corneal changes in these same layers in patients with other anterior corneal diseases including keratokonjunctivits sicca epithelium basement membrane dystrophy and limbal stem cell disease
At last regeneration of the corneal surface after Belamaf discontinuation has been described and is expected but detailed information on the time to corneal rehabilitation as well as confocal microscopic follow-up of epithelial and neuronal layers during this time is warranted The purpose of this monocentric prospective longitudinal study is to answer these specific research questions in a combined clinical approach using corneal confocal microscopy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None