Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641882
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Retrospective Chart Review of Patients with Acanthamoeba Keratitis Who Have Received 08 Mgml Polihexanide
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retrospective Chart Review of Patients with Acanthamoeba Keratitis Who Have Received 08 Mgml Polihexanide As Part of a Compassionate Use Program a Non-interventional Study with Secondary Use of Data
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a non-interventional study with secondary use of data The study will be a site-based retrospective review of medical chart of patients with AK who initiated and completed a treatment with 08 mgml polihexanide as part of a compassionate use program Patientlevel data will be abstracted from medical chart of eligible patients at participating sites and imputed in an electronic case report form eCRF Baseline Time 0 is the date of initiation of 08 mgml polihexanide The study period is the period from T0 to the end of treatment The clinical outcome needs to be confirmed at least 30 days after the conclusion of the treatment
Detailed Description:
Acanthamoeba keratitis AK is an ultra-rare potentially devastating ocular infection that occurs primarily in contact lens wearers The estimated incidence in Europe varies between 1 and 3 casesmillion people per year AK is caused by a ubiquitous free-living protozoan that is present in air soil dust fresh water seawater and bottled water The amoebic organism exists both as dormant cysts and active trophozoites The cysts are highly resilient and can withstand a wide variety of physical conditions and drugs which makes medical treatment of AK both difficult and protracted If left untreated the cure rate is low with most patients needing keratoplasty and some of them requiring enucleation There is currently no approved pharmacological treatment for AK Available treatment options are represented by off-label antiseptic products which are either imported or compounded the most used being biguanides polihexanide-PHMB- or chlorhexidine given alone or in combination with a diamidine propamidine or hexamidine The actual reported medical cure rate with no surgery is approximately 60 in addition almost 50 of patients have a poor outcome defined as a poor visual acuity andor necessity of ocular surgery Polihexanide 08 mgml an eye drops solution developed and manufactured by SIFI SpA Italy has the potential to become the first treatment approved for the treatment of AK Its efficacy and safety were demonstrated in the pivotal clinical study 043SI EUDRACT no 2016-001823-30 ClinicalTrialsgov NCT03274895 in which the mean 95 IC cure rate with no surgery was 848 739-925 with a median 95 IC time-to-cure of 146 94-217 days In addition no major safety issues were observed during the trial A positive opinion from the Committee for Medicinal Products for Human Use at EMA is expected in Q22024 Polihexanide 08 mgml has been made available in Italy by SIFI SpA through a compassionate use program CUP since November 2022 Compassionate use program version 11-ITA-Aug 11 2022 As of December 2023 the treatment with 08 mgml polihexanide was approved for 71 patients with AK SIFI prepared this protocol to conduct a retrospective medical chart review of patients which already completed the treatment with 08 mgml polihexanide as part of the CUP The expected number of evaluable patients is 40 According to the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance ENCePP this will be a Non-Interventional Study as defined in the Directive 200120EC with secondary use of data The protocol was prepared following the good practices report of the ISPEISPOR task force
The expected contribution from this study will be to expand patients exposure to polihexanide 08 mgml and provide further information on its effectiveness and safety when used in the clinical practice compared with the findings observed in the pivotal clinical trial
The expected contribution from this study will be to expand patients exposure to polihexanide 08 mgml and provide further information on its effectiveness and safety when used in the clinical practice compared with the findings observed in the pivotal clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None