Intravitreous CytokinE Level in pAtient With retiNal Detachment (ICELAND)

• ClinicalTrials.gov Identifier: NCT03318588
• Recruitment Status: Unknown
• First Posted: October 24, 2017
• Last Update Posted: October 24, 2017
• Sponsor: Central Hospital, Nancy, France
• 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.

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

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