Status:
COMPLETED
Cyclosporine Implant for Ocular Graft-Versus-Host Disease
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Graft Vs Host Disease
Eligibility:
All Genders
9+ years
Phase:
PHASE1
Brief Summary
Graft-vs.-Host Disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation (SCT) commonly affecting the skin, liver, gastrointestinal tract, and eye. The most common c...
Detailed Description
The objective of this randomized pilot study is to investigate the safety and potential efficacy of a CsA implant in participants with lacrimal gland involvement and aqueous tear deficiency related to...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be eligible for the study each participant must satisfy all of the following inclusion criteria:
- Male or female greater than or equal to 9 years of age.
- Must be greater than or equal to 30 days post-hematopoietic stem cell transplantation (SCT) and have systemic GVHD diagnosed by the transplant physician.
- Must have lacrimal gland dysfunction from GVHD following SCT as defined by Schirmer tear test score (with anesthesia) of greater than or equal to 1 mm but less than or equal to 9 mm in both eyes.
- Must have open puncta and no puncta plug placement at the time of enrollment.
- If using topical corticosteroids, must be equal dose in both eyes of less than or equal to 4 drops per day.
- Topical lubrication using tear substitutes (includes eye drops, gels, and ointments) are permitted with equal dosing in both eyes.
- Must understand and sign informed consent or assent.
- Must be willing and able to comply with study evaluation and testing schedule.
- Females of childbearing potential and all males must agree to use an effective form of birth control for duration of the study.
- Females of childbearing potential must have a negative serum pregnancy test at baseline evaluation.
- EXCLUSION CRITERIA:
- To be eligible for the study, participants must not satisfy any of the following exclusion criteria.
- Use of a topical ophthalmic cyclosporine formulation less than or equal to 30 days prior to enrollment.
- Diagnosed with active ocular infection.
- History of recurrent herpes keratitis or active disease less than or equal to 6 months prior to enrollment.
- Aqueous tear deficiency or KCS related to previous irradiation, Stevens-Johnson syndrome, cicatricial pemphigoid, alkali burns, trachoma or Sjogren's syndrome.
- Seropositive for Hepatitis C (i.e. positive anti-HCV antibody) or seropositive for HIV with testing performed no earlier than 4 months before the date of stem cell transplantation.
- Diagnosis of active sarcoidosis.
- Use of a drug with anticholinergic activity within less than 4 times the half-life of the drug prior to enrollment (e.g., carbamazepine \[Tegretol (R)\] has a half-life of 16-24 hours so must not be used within 4 days of enrollment).
- Use of an investigational drug for eye disease within 30 days of enrollment.
- Known allergy or hypersensitivity to cyclosporine, fluorescein, or lissamine green.
- Uncontrolled systemic disease or serious illness that could, in the investigator's opinion, interfere with the participant's ability to comply with study therapy, required follow-up testing, or interfere with interpretation of the study results.
- Pregnant or lactating female.
- Serum creatinine greater than 2.5 mg/dL, absolute neutrophil count (ANC) less than 750/MicroL Platelet count less than 25,000/MicroL, Partial Thromboplastin Time (PTT), or International Normal Ratio (INR) or Prothrombin Time (PT) exceeding the institutional upper limit of normal would require review by the Hematologist for surgical clearance. Hematologist review of the abnormal coagulation value and approval for surgery must be documented in the medical record prior to the surgical procedure.
- Participants that have received total body irradiation or direct eye/orbital radiation greater than 5000 cGy. (Potential participants will be assessed by a study clinician to determine that the cause of the dry eye symptoms is due to GVHD and not radiation. The clinician, in conjunction with the oncology staff as needed, will also assess the participant's clinical exam and medical history).
Exclusion
Key Trial Info
Start Date :
October 14 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00102583
Start Date
October 14 2004
End Date
March 15 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892