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Trial record 1 of 4 for:    cytokines | retinal detachment
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Intravitreous CytokinE Level in pAtient With retiNal Detachment (ICELAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03318588
Recruitment Status : Unknown
Verified October 2017 by Docteur Jean-Baptiste CONART, Central Hospital, Nancy, France.
Recruitment status was:  Not yet recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Docteur Jean-Baptiste CONART, Central Hospital, Nancy, France

Tracking Information
First Submitted Date October 19, 2017
First Posted Date October 24, 2017
Last Update Posted Date October 24, 2017
Estimated Study Start Date November 2017
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 19, 2017)
Intravitreous cytokine levels [ Time Frame: up to one month after surgery ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intravitreous CytokinE Level in pAtient With retiNal Detachment
Official Title Intravitreous CytokinE Level in pAtient With retiNal Detachment
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients from the department of Ophthalmology (Nancy University Hospital)
Condition Retinal Detachment
Intervention Procedure: Vitrectomy
Pars plana vitrectomy
Study Groups/Cohorts
  • Case
    Patients undergoing vitrectomy for primary retinal detachment
    Intervention: Procedure: Vitrectomy
  • Control
    Patients undergoing vitrectomy for idiopathic macular hole
    Intervention: Procedure: Vitrectomy
Publications * Conart JB, Blot G, Augustin S, Millet-Puel G, Roubeix C, Beguier F, Charles-Messance H, Touhami S, Sahel JA, Berrod JP, Léveillard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 19, 2017)
74
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of retinal detachment or intraocular inflammatory diseases
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03318588
Other Study ID Numbers 2017-A02195-48
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Docteur Jean-Baptiste CONART, Central Hospital, Nancy, France
Study Sponsor Central Hospital, Nancy, France
Collaborators Not Provided
Investigators
Principal Investigator: Jean-Baptiste CONART, MD Brabois Hospital, Department of Ophthalmology
PRS Account Central Hospital, Nancy, France
Verification Date October 2017