Clinical trial NCT04636918: Ikervis for DED Due to GVHD Post Allo-HSCT
Official title: Ikervis for Prophylaxis of Dry Eye Disease Due to Graft vs Host Disease Post Allogeneic Haemtopoietic Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Leukemia (Both ALL and AML)
MDS-EB-1
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Dry eye disease (DED) is a common sequelae of graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Since Ikervis is reported to be a safe and efficacious treatment of DED associated with chronic GVHD, our study would like to study the efficacy of prophlactic Ikervis in preventing ocular GVHD development.

Detailed description: This is a prospective single arm interventional study.

The recruitment period will be over 12-18 months to enroll all suitable patients. The total duration of prophylaxis will be for 1 year. After completion of the period of prophylaxis, the patients will be followed up as a non-study patient as clinically indicated.

Forty subjects, undergoing allo-HSCT, will be recruited from the Singapore National Eye Centre upon referral from the Department of Hematology, Singapore General Hospital and followed up at least 5 times over a period of 12 months at the Singapore Eye Research Institute.

The images of the subject eyes will be recorded and stored electronically. These images (corneal fluorescein staining score, Lipiview, meibography, conjunctival redness, tear stability assessment) will be used in the analysis of outcome measures. The Lipiview result is in video format.

Eligibility criteria: Inclusion Criteria:

* Age 13 and above
* Able to give informed consent

Exclusion Criteria:

* Presence of concurrent disease
* Unable to complete the follow up

Primary outcomes:
measure: To assess change in basline visual acuity using LogMAR chart with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline, 3 months, 6 months and 1 year post-HSCT follow up
measure: To assess change in baseline intraocular pressure using non-contact tonometry with 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline, 3 months, 6 months and 1 year post-HSCT follow up
measure: To assess change in baseline anterior ocular health using slit lamp examination with 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline screening and 1 year post-HSCT follow up
measure: To assess change in baseline posterior ocular health using fundus examination with 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline screening and 1 year post-HSCT follow up
measure: To assess change of baseline dry eye symptoms with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
measure: To assess change of baseline non-invasive tear break up time with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
measure: To assess change of baseline conjunctival redness with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
measure: To assess change of baseline tear lipid thickness with prophylactic Ikervis 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline and 1 year post-HSCT follow up
measure: To assess change of baseline Meibomian gland status with prophylactic Ikervis 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline and 1 year post-HSCT follow up
measure: To assess change of baseline tear cytokines with prophylactic Ikervis after 3 to 5 weeks after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
measure: To assess change of conjunctival impression cytology 3 to 5 weeks after prophylactic Ikervis with 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: 3 to 5 weeks from baseline (Pre-HSCT) and 1 year post-HSCT follow up
measure: To assess change of baseline corneal fluorescein staining score with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
measure: To assess change of baseline Meibomian gland expressibility with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
measure: To assess Quality of Life Questionnaire at 12 months post Haematopoietic Stem Cell Transplant.
timeFrame: 1 year post-HSCT follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Senior Consultant
name: Li Lim
role: PRINCIPAL_INVESTIGATOR
References: