Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348602
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-10-30
Brief Title:
Evaluation of Safety Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT
Sponsor:
Hospital Universitario Dr Jose E Gonzalez
Organization:
Hospital Universitario Dr Jose E Gonzalez
Study Overview
Official Title:
Evaluation of Safety and Efficacy for the Prevention of Ocular Graft-versus-host Disease With Ophthalmic Tacrolimus vs Ophthalmic Cyclosporine in Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplant Recipients
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Chronic GVHD cGVHD is a predominant cause of mortality and disability not related to relapse it occurs in 30 to 70 of patients The majority of patients with cGVHD present with ocular involvement with a reported incidence of 40-60 Symptoms can range from mild dry eye syndrome to severe epithelial defects that can generate corneal perforation and loss of vision The most accepted pharmacological modality is the topical application of cyclosporine A on the other hand tacrolimus has shown greater immunosuppressive power when used in ocular GVHD However this effectiveness is limited since by the time the manifestations appear there is already permanent damage to the lacrimal gland due to the lymphocytic infiltration so it is necessary to use a prevention strategy before these manifestations appear Previously the employment of ocular cyclosporine drops as ocular GVHD prophylaxis was assessed to evaluate safety and effectiveness showing that it is well tolerated and can limit the appearance of severe dry eye manifestations in a small group of patients The purpose of this work is to compare the two modalities currently accepted for the treatment of the disease but in a prophylactic way topical ciclosporin A against topical tacrolimus to determine the safety and efficiency of each of them as a preventive measure to limit the risk of developing the appearance of ocular cGVHD and the permanent consequences that this generates
Detailed Description:
After being informed about the study and potential risks all patients giving written informed consent will be assigned a participant number to anonymize their data and collect information including age sex diagnosis stage of disease type of procedure and conditioning chemotherapy Additionally an ophthalmology evaluation will be conducted in the Ophthalmology Department of the University Hospital of the UANL by the study team of ophthalmologists following a standardized method and using a worksheet for dry eye and ocular surface evaluation
Participants will be randomized to receive either treatment arm A cyclosporine eye drops or treatment arm B tacrolimus ointment through a stratified method After the hematopoietic stem cell transplant HSCT information will be collected such as the transplant details eg number of cluster of differentiation 34 CD34 cells infused cell source and any complications during the procedure and medications used for the systemic GVHD prophylaxis as well as the graft date In addition to the standard systemic management protocol for GVHD prevention of the transplant program of the Hematology Service of the Hospital University UANL cyclosporine or tacrolimus will be administered to participants once grafting is demonstrated defined as the presence in the blood count of a neutrophil count that is equal to or greater than to 500mm3 and platelet count equal to or greater than 20000mm3
Treatment arm A topical cyclosporine 01 ocular drops twice daily one drop in each eye with a 12-hour difference between each dose for 12 continuous months The commercial presentation that we will use has the following formula Each milliliter of 01 solution contains Cyclosporine A 10 mg cbp 10 ml
Treatment arm B tacrolimus ointment to be applied approximately 1cm or the amount to cover the lower fornix twice a day in each eye with a difference of 12 hours between each dose for 12 continuous months The presentation of the medicine in ointment has a 10 gr tube with 003 drug
Ophthalmological evaluations will be carried out at the initial visit before the bone marrow transplant and scheduled subsequent visits at the time of transplant graft variable depending on the type of transplant between days 10 and 21 approximately and 3 6 9 and 12 months from the start of treatment day of graft Also they will be evaluated during all follow-up visits to the transplant department of the Hematology Service assessing adherence and tolerance to the medication through direct questioning The severity of ocular GVHD will be established based on the NIH criteria and the severity criteria of the international consensus on the severity of chronic ocular GVHD ICCGVHD
Ophthalmological variables to be evaluated
Tear breakup time Schirmers test esthesiometry Keratograph 5M Topographer Dry Eye Assessment upper and lower tarsus Meibomian Gland imaging Keratograph 5M tear osmolarity metalloproteinase 9 levels in tears
Corneal and conjunctival staining measured with the Oxford Scale and the Collaborative Longitudinal Evaluation of Keratoconus CLEK Scale and SICCA Ocular Staining Score OSS
Participants will be randomized to receive either treatment arm A cyclosporine eye drops or treatment arm B tacrolimus ointment through a stratified method After the hematopoietic stem cell transplant HSCT information will be collected such as the transplant details eg number of cluster of differentiation 34 CD34 cells infused cell source and any complications during the procedure and medications used for the systemic GVHD prophylaxis as well as the graft date In addition to the standard systemic management protocol for GVHD prevention of the transplant program of the Hematology Service of the Hospital University UANL cyclosporine or tacrolimus will be administered to participants once grafting is demonstrated defined as the presence in the blood count of a neutrophil count that is equal to or greater than to 500mm3 and platelet count equal to or greater than 20000mm3
Treatment arm A topical cyclosporine 01 ocular drops twice daily one drop in each eye with a 12-hour difference between each dose for 12 continuous months The commercial presentation that we will use has the following formula Each milliliter of 01 solution contains Cyclosporine A 10 mg cbp 10 ml
Treatment arm B tacrolimus ointment to be applied approximately 1cm or the amount to cover the lower fornix twice a day in each eye with a difference of 12 hours between each dose for 12 continuous months The presentation of the medicine in ointment has a 10 gr tube with 003 drug
Ophthalmological evaluations will be carried out at the initial visit before the bone marrow transplant and scheduled subsequent visits at the time of transplant graft variable depending on the type of transplant between days 10 and 21 approximately and 3 6 9 and 12 months from the start of treatment day of graft Also they will be evaluated during all follow-up visits to the transplant department of the Hematology Service assessing adherence and tolerance to the medication through direct questioning The severity of ocular GVHD will be established based on the NIH criteria and the severity criteria of the international consensus on the severity of chronic ocular GVHD ICCGVHD
Ophthalmological variables to be evaluated
Tear breakup time Schirmers test esthesiometry Keratograph 5M Topographer Dry Eye Assessment upper and lower tarsus Meibomian Gland imaging Keratograph 5M tear osmolarity metalloproteinase 9 levels in tears
Corneal and conjunctival staining measured with the Oxford Scale and the Collaborative Longitudinal Evaluation of Keratoconus CLEK Scale and SICCA Ocular Staining Score OSS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None