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NCT04636918: Ikervis

Ikervis for DED Due to GVHD Post Allo-HSCT

Status unknown Phase 4 Last updated 19 November 2020
What this trial tests

Phase 4 trial testing Cyclosporine Ophthalmic in Leukemia (Both ALL and AML) in 40 participants. Status unknown.

Timeline
28 November 2019
Primary endpoint
22 August 2022
30 December 2022

Quick facts

Lead sponsorSingapore Eye Research Institute
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment40
Start date28 November 2019
Primary completion22 August 2022
Estimated completion30 December 2022
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

Singapore Eye Research Institute

Who can join

Adults 13 to 95, any sex, with Leukemia (Both ALL and AML) or MDS-EB-1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Regenerative treatment of ophthalmic diseases with stem cells: Principles, progress, and challenges.
    Niu Y, Ji J, Yao K, Fu Q. · · 2024 · cited 25× · PMID 38586868 · DOI 10.1016/j.aopr.2024.02.001
  2. Recent advances in ocular graft-versus-host disease.
    Cheng X, Huang R, Huang S, Fan W, et al · · 2023 · cited 24× · PMID 36761771 · DOI 10.3389/fimmu.2023.1092108
  3. Conjunctival T Cell Profile in Allogeneic Hematopoietic Stem Cell Transplant Patients after Instilling Topical Cyclosporine-A 0.1% Cationic Emulsion.
    Tong L, Lim EWL, Yeo SWJ, Hou A, et al · · 2023 · cited 7× · PMID 36856978 · DOI 10.1007/s40123-023-00686-0
  4. Tackling visual impairment: emerging avenues in ophthalmology.
    Lin F, Su Y, Zhao C, Akter F, et al · · 2025 · cited 4× · PMID 40357281 · DOI 10.3389/fmed.2025.1567159
  5. Tear Cytokine Changes up to One Year After Allogeneic Hematopoietic Stem Cell Transplant: Effect of Daily Topical Cyclosporine-A 0.1% Emulsion.
    Tong L, Liu YC, Yeo SWJ, Liu C, et al · · 2025 · cited 1× · PMID 40565378 · DOI 10.3390/ijms26125915

Verify or expand the search:

Other recruiting trials for Leukemia (Both ALL and AML)

Currently open trials in the same condition.

Other Singapore Eye Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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