Sickle Cell DiseaseSCMevolNCT07877753
Evolution of Sickle Cell Maculopathy
An observational study of Sickle Cell Disease and Macula Thickening, run by Christophe Orssaud at 1 site in France.
Trial summary
To investigate retrospectively the longitudinal evolution of vascular defects in patients with typical or atypical forms of SCM. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Disease, Macula Thickening, Macula Abnormality
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A single ophthalmological department the data of adult patients that underwent macular OCT-A at different ophthalmological assessments
Who may be able to join
- Sickle cell maculopathy on OCT-A At least two consultation
Who cannot join
- Opposition that data were used for studies Poor OCT-A images quality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Vascular Defect in Macular Sickle Cell Maculopathy by OCT-A
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.
- Conditions
- Sickle Cell Disease, Macula Thickening, Macula Abnormality
- Keywords
- sickle cell disease, Sickle cell maculopathy, OCT-A
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular density
Measure vascular density in the superficial and deep plexuses of the same patient over time
Measured: From january 2020 to January 2026
Secondary outcomes (1)
Macular thickness
Analyze of the macular thickness on OCT
Measured: From january 2020 to January 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Sep 2026
- Primary completion20 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christophe Orssaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christophe Orssaud, Hôpital Necker-Enfants Malades
- Investigators
- christophe Orssaud, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877753
- Sponsor's protocol ID
- SCDevlOCTa
- Acronym
- SCMevol
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Need to be in accordance with legal national reglementation
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Vascular Defect in Macular Sickle Cell Maculopathy by OCT-A
- ClinicalTrials.gov ID
- NCT07877753
- Acronym / sponsor ID
- SCMevol / SCDevlOCTa
- Conditions
- Sickle Cell Disease, Macula Thickening, Macula Abnormality
- Keywords
- sickle cell disease, Sickle cell maculopathy, OCT-A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Christophe OrssaudUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 20 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate retrospectively the longitudinal evolution of vascular defects in patients with typical or atypical forms of SCM.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A single ophthalmological department the data of adult patients that underwent macular OCT-A at different ophthalmological assessments
Key inclusion criteria (1 listed)
- Sickle cell maculopathy on OCT-A At least two consultation
Key exclusion criteria (1 listed)
- Opposition that data were used for studies Poor OCT-A images quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vascular density
Time frame: From january 2020 to January 2026
Measure vascular density in the superficial and deep plexuses of the same patient over time
1 secondary outcome
Macular thickness
Time frame: From january 2020 to January 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 37948742Orssaud 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.
- Individual participant dataSharing planned: Undecided. Need to be in accordance with legal national reglementation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
christophe Orssaud, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Macula Thickening, run by Christophe Orssaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular density (time frame: From january 2020 to January 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07877753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.