Ischemia Clinical Trial
— RetinaCellOfficial title:
Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
Verified date | October 2018 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | January 2020 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - diagnosis of Ischemic Retinopathy - Enlargement of foveal avascular zone-FAZ (ischaemia or capillary drop out of >30% on Fluorescein retinography - logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse - Able (in the Investigator's opinion) and willing to comply with all study requirements Exclusion Criteria: - previous ocular surgery other than cataract - presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation - other ophthalmic disease like glaucoma and uveitis - previous history of blood disorders like leukemia - known allergy to fluorescein or indocyanine green |
Country | Name | City | State |
---|---|---|---|
Brazil | Rubens Siqueira Research Center | Sao Jose do Rio Preto | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Siqueira RC, Messias A, Gurgel VP, Simões BP, Scott IU, Jorge R. Improvement of ischaemic macular oedema after intravitreal injection of autologous bone marrow-derived haematopoietic stem cells. Acta Ophthalmol. 2015 Mar;93(2):e174-6. doi: 10.1111/aos.12473. Epub 2014 Jun 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in size of FAZ at 48 weeks | 1 day to 48 weeks | ||
Secondary | Change in central foveal thickness and best corrected visual acuity at 48 weeks | 1 day to 48 weeks |
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