The role of Red cell characteristics, Angiogenesis, Viscosity and Oxygenation in the pathophysiology of Sickle cell related retinopathy (RAVOS study)

Recruiting

Conditions: sickle cell disease related retinal damage
sickle cell retinopathy
10018902
10047060

Registration Number: NL-OMON53639

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following 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

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The difference in red blood cell characteristics (point of sickling) between<br /><br>patients with and without (P)SCR in both genotypes<br /><br>2. The difference in plasma levels of parameters representing the level of<br /><br>systemic angiogenesis activity (CD105, VEGF, CTGF and angiopoietin-2) between<br /><br>patients with and without P()SCR in both genotypes<br /><br>3. The difference in oxygenation of the retina by assessing the vessel density<br /><br>with angio-OCT and by assessing the oxygen saturation in the retinal arterioles<br /><br>and venules with the oxymap scan in patients with and without (P)SCR in both<br /><br>genotypes<br /><br>4. The difference in whole blood viscosity between patients with and without<br /><br>(P)SCR in both genotypes</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Association between retinal vessel density assessed by OCT-angiography,<br /><br>oxygen saturation assessed by an Oxymap scan and red blood cell characteristics<br /><br>(deformity, adhesion and point of sickling upon hypoxia)<br /><br>2. Association between sex, age, and genotype and the biomarkers of angiogenesis<br /><br>3. Association between hemoglobin, and HbF and biomarkers of angiogenesis<br /><br>4. Associations between whole blood viscosity and genotype</p><br>