NCT03318588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2018

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

October 19, 2017

Last Update Submit

July 18, 2022

Conditions

Keywords

Retinal detachmentPhotoreceptor apoptosisCytokine

Outcome Measures

Primary Outcomes (1)

  • Intravitreous cytokine levels

    up to one month after surgery

Study Arms (2)

Case

Patients undergoing vitrectomy for primary retinal detachment

Procedure: Vitrectomy

Control

Patients undergoing vitrectomy for idiopathic macular hole

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE

Pars plana vitrectomy

CaseControl

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from the department of Ophthalmology (Nancy University Hospital)

You may qualify if:

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

You may not qualify if:

  • History of retinal detachment or intraocular inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brabois Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Retinal Detachment

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jean-Baptiste CONART, MD

    Brabois Hospital, Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 24, 2017

Study Start

November 15, 2017

Primary Completion

June 28, 2018

Study Completion

October 11, 2018

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations