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CompletedNCT07877753SCMevolUpdated Oct 16, 2026

Evolution of Sickle Cell Maculopathy

An observational study in Sickle Cell Disease, Macula Thickening and Macula Abnormality, sponsored by Christophe Orssaud. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Christophe Orssaud · Observational

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
34
Sex
All
01

Study summary

To investigate retrospectively the longitudinal evolution of vascular defects in patients with typical or atypical forms of SCM.

Read the detailed description

Several questions regarding this SCM are still unsolved. Its physio pathogenic mechanisms are not clearly understood. In addition, the mean age of onset and the evolution of these retinal and vascular defects have not been fully studied. Recently, "atypical" forms of SCM have been reported, in which there are areas of reduction or disappearance of retinal vascularization at the level of the superficial and deep plexuses but without retinal atrophy on OCT. At last, it remains unclear whether SCM evolved over time or remained stable with age The investigators will retrospectively analyze the longitudinal evolution of vascular defects and retinal thickness in typical or atypical forms of SCM using OCT and OCT-A images. OCT-A images will be processed using the AngioTool64 software to obtain vascular density in SCP and DCP. A 5% variation in vascular density will be considered as significant, regardless of its direction.

02

Conditions studied

  • Sickle Cell Disease
  • Macula Thickening
  • Macula Abnormality

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Keywords

  • sickle cell disease
  • Sickle cell maculopathy
  • OCT-A
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In context

Anemia, Sickle Cell

1,125 studies on the registry are indexed under Anemia, Sickle Cell; 239 are open to participants now.

This study's enrollment of 34 is below the median of 100 across 295 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

This is the only study on the registry with Christophe Orssaud as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A single ophthalmological department the data of adult patients that underwent macular OCT-A at different ophthalmological assessments

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Sickle cell maculopathy on OCT-A At least two consultation

Exclusion criteria

Exclusion Criteria:

  • Opposition that data were used for studies Poor OCT-A images quality
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
34 participants (actual)
Patient registry
No

Groups and cohorts

  • typical sickle cell maculopathy

    eyes with thinning of the inner retinal layers with a reduction of vascular flow in both superficial capillary plexuses and deep capillary plexuses

  • atypical sickle cell maculopathy

    Eyes with an absence retinal atrophy on OCT in territories of reduction or disappearance of retinal vascularization in both superficial capillary plexuses and deep capillary plexuses

06

What researchers measure

Primary outcomes

  1. Vascular density

    Measure vascular density in the superficial and deep plexuses of the same patient over time

    Time frame: From january 2020 to January 2026

Secondary outcomes

  1. Macular thickness

    Analyze of the macular thickness on OCT

    Time frame: From january 2020 to January 2026

07

Study locations

1 site
  • Hopital Européen Georges Pompidou
    Paris, 75015, France
08

References and documents

Publications

  • Orssaud C, Flammarion E, Michon A, Ranque B, Arlet JB. ATYPICAL FOVEAL AND PARAFOVEAL ABNORMALITIES IN SICKLE CELL DISEASE. Retina. 2024 Mar 1;44(3):506-514. doi: 10.1097/IAE.0000000000003987. PubMed 37948742 ↗

Individual participant data

Plan to share: Undecided — Need to be in accordance with legal national reglementation

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2026 to primary completion in Sep 2026, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 16, 2026
StartActual
Sep 1, 2026
Primary completionActual
Sep 20, 2026
CompletionActual
Oct 1, 2026
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07877753
Lead sponsor
Christophe Orssaud
Responsible party
Christophe Orssaud (MD, Hôpital Necker-Enfants Malades) — Sponsor-investigator
First posted
Oct 16, 2026
Start date
Sep 1, 2026
Primary completion
Sep 20, 2026
Completion
Oct 1, 2026
Last update
Oct 16, 2026

Study contacts

christophe Orssaud, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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