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CompletedNCT03318588ICELANDUpdated Jul 20, 2022

Intravitreous CytokinE Level in pAtient With retiNal Detachment

An observational study in Retinal Detachment, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
74
Ages
18 Years and older
Sex
All
01

Study summary

Photoreceptor apoptosis is the basis for permanent visual loss in a number of retinal disorders including age-related macular degeneration (AMD) and retinal detachment (RD). Thus, despite tremendous advances in vitreoretinal surgery and management of rhegmatogenous RD leading to a primary reattachment rate over 95%, some patients show poor visual recovery because of photoreceptor apoptosis.

Physiologically, microglial cells (resident macrophages) are present only in the inner retina. The subretinal space, located between the retinal pigment epithelium (RPE) and the photoreceptor outer segments (POS), is devoid of all mononuclear phagocytes and form a zone of immune privilege. In AMD, several studies showed a strong association between subretinal mononuclear phagocytes infiltration and advanced forms of AMD. Experimental work in mice suggest that this infiltration plays an important role in the pathogenesis of this condition by producing inflammatory cytokines.

RD-induced photoreceptor apoptosis might result from similar mechanisms. The aim of this study is to determine the cytokine profile in vitreous samples from patients with RD and to compare it with those from control patients with macular hole.

02

Conditions studied

  • Retinal Detachment

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Keywords

  • Retinal detachment
  • Photoreceptor apoptosis
  • Cytokine
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In context

Retinal Detachment

199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.

This study's enrollment of 74 is above the median of 60 across 58 observational studies indexed under Retinal Detachment.

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Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients from the department of Ophthalmology (Nancy University Hospital)

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

  • Patients with primary retinal detachment requiring vitrectomy
  • Patients with idiopathic macular hole requiring vitrectomy

Exclusion criteria

Exclusion Criteria:

  • History of retinal detachment or intraocular inflammatory diseases
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
74 participants (actual)
Patient registry
No

Groups and cohorts

  • Case

    Patients undergoing vitrectomy for primary retinal detachment

    Procedure: Vitrectomy

  • Control

    Patients undergoing vitrectomy for idiopathic macular hole

    Procedure: Vitrectomy

Interventions

  • ProcedureVitrectomy

    Pars plana vitrectomy

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What researchers measure

Primary outcomes

  1. Intravitreous cytokine levels

    Time frame: up to one month after surgery

07

Study locations

1 site
  • Brabois Hospital
    Vandœuvre-lès-Nancy, 54500, France
08

References and documents

Publications

  • Conart JB, Blot G, Augustin S, Millet-Puel G, Roubeix C, Beguier F, Charles-Messance H, Touhami S, Sahel JA, Berrod JP, Leveillard T, Guillonneau X, Delarasse C, Sennlaub F. Insulin inhibits inflammation-induced cone death in retinal detachment. J Neuroinflammation. 2020 Nov 26;17(1):358. doi: 10.1186/s12974-020-02039-1. PubMed 33243251 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Jun 2018, 7 months.

Of 22 observational studies under Retinal Detachment, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 7 months is below that.

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

Registered
Oct 19, 2017
First posted
Oct 24, 2017
StartActual
Nov 15, 2017
Primary completionActual
Jun 28, 2018
CompletionActual
Oct 11, 2018
Last update
Jul 20, 2022
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.
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03318588
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Docteur Jean-Baptiste CONART (Medical Doctor, Central Hospital, Nancy, France) — Principal investigator
First posted
Oct 24, 2017
Start date
Nov 15, 2017
Primary completion
Jun 28, 2018
Completion
Oct 11, 2018
Last update
Jul 20, 2022

Study contacts

Jean-Baptiste CONART, MD
principal investigator · Brabois Hospital, Department of Ophthalmology

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 Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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