Sickle Cell Disease Clinical Trial
— RAVOSOfficial title:
The Role of Red Cell Characteristics, Angiogenesis, Viscosity and Oxygenation in the Pathophysiology of Sickle Cell Related Retinopathy
NCT number | NCT06396403 |
Other study ID # | NL81111.018.22 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2023 |
Est. completion date | December 2024 |
Objective: to gain insight in the pathogenesis, to identify biomarkers to recognize patients at risk for proliferative SCR and to investigate its associations with clinical and laboratory characteristics. Endpoints: The investigators will determine the difference in the above named parameters between patients with and without PSCR Study design: This case control study will include adult sickle cell disease patients with the HbSS or HbSC genotype. For both genotypes, 20 patients without sickle cell retinopathy (SCR) and 20 patients with PSCR will be included, resulting in a total of 80 patients. Venous blood samples and retinal imaging scans will be collected for each included patient.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Minimum age of 18 years - HbSC or HbSS genotype - Recent ophthalmologic examination (up to 2 years prior) or (willingness to attend) upcoming examination Exclusion Criteria: - Age below 18 years - Genotype other than HbSC or HbSS - No recent ophthalmologic examination and no intention to visit the outpatient clinic for ophthalmic and hematologic examination - Participation in trials with either crizanlizumab, voxelotor or mitapivat. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in Red blood cell characteristics (Oxygenscan) | The difference in red blood cell characteristics (point of sickling) between patients with and without PSCR in both genotypes | Immediately after the venepuncture | |
Primary | Differences in Angiogenesis biomarkers | The difference in plasma levels of parameters representing the level of systemic angiogenesis activity (CD105, VEGF, CTGF and angiopoietin-2) between patients with and without PSCR in both genotypes | Immediately after the venepuncture | |
Primary | Differences in Retinal Oxygenation | The difference in oxygenation of the retina by assessing the vessel density with angio- OCT and by assessing the oxygen saturation in the retinal arterioles and venules with the Oxymap scan in patients with and without PSCR in both genotypes | Immediately after the venepuncture | |
Primary | Differences in Whole blood viscosity | The difference in whole blood viscosity between patients with and without PSCR in both genotypes | Immediately after the venepuncture | |
Secondary | Associations between Oxygenation parameters and Red blood cell characteristics | Association between retinal vessel density assessed by OCT-angiography, oxygen saturation assessed by an Oxymap scan and red blood cell characteristics (deformity, adhesion and point of sickling upon hypoxia) | Immediately after the venepuncture | |
Secondary | Associations between sex, age, and genotype and the biomarkers of angiogenesis | Association between sex, age, and genotype and the biomarkers of angiogenesis | Immediately after the venepuncture | |
Secondary | Association between hemoglobin, and HbF and biomarkers of angiogenesis | Association between hemoglobin, and HbF and biomarkers of angiogenesis | Immediately after the venepuncture | |
Secondary | Associations between whole blood viscosity and genotype | Associations between whole blood viscosity and genotype | Immediately after the venepuncture |
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