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NCT01369914
The Natural History of Graft-Versus-Host Disease in the Eyes
trial in Graft-Versus-Host Disease in 61 participants. Completed in 5 February 2016.
Quick facts
| Lead sponsor | National Eye Institute (NEI) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 61 |
| Start date | 20 May 2011 |
| Estimated completion | 5 February 2016 |
| Sites | 1 location across United States |
Conditions studied
- Graft-Versus-Host Disease — all drugs for Graft-Versus-Host Disease →
Sponsor
National Eye Institute (NEI)
Who can join
18 and older, any sex, with Graft-Versus-Host Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: * Stem cell transplantation (SCT) is used to treat some kinds of cancer, blood cell disorders, and immune disorders. Stem cells from a donor s blood are used to replace the recipient s stem cells in the bone marrow. The recipient s bone marrow can then produce new blood cells. Some of these new cells involved in the immune system are like the donor s cells. Sometimes immune cells from the SCT attack the recipient s normal tissues, including the eyes. This type of immune attack is called graft-versus-host disease, or GVHD. * The symptoms of ocular GVHD include eye pain, irritation, dryness, and inflammation. When it is severe and if it does not respond well to treatment, ocular GVHD may also cause vision loss. Objective: \- To learn more about graft-versus-host disease (GVHD) of the eyes in people who have had stem cell transplantation. Eligibility: * Participants must be at least 18 years of age. * They must be taking part in a study at the National Cancer Institute (NCI) or the National Heart, Lung and Blood Institute (NHLBI). * They must have a SCT scheduled within the next 30 days. Design: * The study lasts for 1 year and includes six visits to the National Eye Institute. (There is an optional visit about 1 month before your SCT.) When possible, visits for this study will be scheduled so that they can be done on the same day as your visits for the NCI or NHLBI protocol that you are taking part in. * At each visit, participants will have a medical exam and an eye history will be taken. They will have an eye exam and a test to measure the ability to make tears. Those in the study will also have tear fluid collected for analysis in a lab. Tear fluid collection is a painless process. Blood will be drawn during certain visits if it has not already been collected by the transplant team.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ocular surface indicators and biomarkers in chronic ocular graft-versus-host disease: a prospective cohort study.
Pietraszkiewicz AA, Payne D, Abraham M, Garced A, et al · · 2021 · cited 10× · PMID 33686249 · DOI 10.1038/s41409-021-01254-5
Verify or expand the search:
- PubMed search for NCT01369914
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Graft-Versus-Host Disease
Currently open trials in the same condition.
- NCT06423131 — Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT · NA · recruiting
- NCT05675930 — A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transpl · Phase 2 · recruiting
- NCT00001529 — Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives · recruiting
Other National Eye Institute (NEI) trials
Trials by the same sponsor.
- NCT06491615 — National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and · recruiting
- NCT04289571 — Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease · Phase 1 · recruiting
- NCT04833361 — Potential Environmental Causes of Uveal Coloboma · completed
- NCT06670989 — Training to Modify Fixational Eye Movements for Optimizing Visual Performance in People With Central Vision Loss · NA · active not recruiting
- NCT04591483 — Stargardt-like Macular Dystrophy (STDG3) Secondary to Mutations in ELOVL4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01369914 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Eye Institute (NEI)
- Last refreshed: 3 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01369914.
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