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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03318588
Other study ID # 2017-A02195-48
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2017
Est. completion date October 11, 2018

Study information

Verified date July 2022
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date October 11, 2018
Est. primary completion date June 28, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Vitrectomy
Pars plana vitrectomy

Locations

Country Name City State
France Brabois Hospital VandÅ“uvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intravitreous cytokine levels up to one month after surgery
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