Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis (Endophtalmitis)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01768078
First received: January 8, 2013
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

One useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis.


Condition Intervention Phase
Post-operative Endophthalmitis
Procedure: Intravitreal injection of Betamethasone + antibiotics
Procedure: Intravitreal injection of antibiotics
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Measure the evolution of visual acuity [ Time Frame: up to12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: September 2008
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: with corticoids Procedure: Intravitreal injection of Betamethasone + antibiotics
without corticoids Procedure: Intravitreal injection of antibiotics

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients male or female with no age limit
  • Hospitalized for the diagnosis and treatment of acute endophthalmitis following cataract surgery
  • Who had given their consent after being informed about intravitreal corticotherapy

Exclusion Criteria:

  • Patients who refused or were unable to give their consent
  • Prior intravitreal corticotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768078

Contacts
Contact: Catherine CREUZOT-GARCHER 3 80 29 51 73 ext +33 catherine.creuzot-garcher@chu-dijon.fr

Locations
France
CHU de Besançon Recruiting
Besançon, France, 25000
Contact: Bernard DELBOSC       ophtalmologie@chu-besancon.fr   
Principal Investigator: Bernard DELBOSC         
Sub-Investigator: Romain FEBVRE         
CHU Recruiting
Dijon, France, 21000
Contact: Catherine CREUZOT-GARCHER    3 80 29 51 73 ext +33    catherine.creuzot-garcher@chu-dijon.fr   
Principal Investigator: Catherine CREUZOT-GARCHER         
Sub-Investigator: Alain BRON         
Sub-Investigator: Alexandre GUILLAUBEY         
Sub-Investigator: Stéphane ARNAVIELLE         
CHU de Grenoble Recruiting
Grenoble, France
Contact: Christophe CHIQUET       cchiquet@chu-grenoble.fr   
Sub-Investigator: Karine PALOMBI         
Sub-Investigator: Viviane VINH         
Principal Investigator: Christophe CHIQUET         
CHU de Nancy Recruiting
Nancy, France, 54000
Contact: Jean-Paul BERROD       jp.berrod@chu-nancy.fr   
Principal Investigator: Jean-Paul BERROD         
Principal Investigator: Jean Toufic MAALOUF         
Sub-Investigator: Pierre LESURE         
Sub-Investigator: Rym OULED-MOUSSA         
Sub-Investigator: Angélique POIRSON         
Sub-Investigator: Grégoire MINOYAN         
Sub-Investigator: Marie-Christine BAZARD         
CHU de Saint Etienne Recruiting
Saint Etienne, France
Contact: Philippe GAIN       philippe.gain@univ-st-etienne.fr   
Principal Investigator: Philippe GAIN         
Sub-Investigator: Gilles THURET         
Sub-Investigator: Nelly CAMPOLMI         
CHU de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Claude SPEEG-SCHATZ       claude.speeg@chru-strasbourg.fr   
Principal Investigator: Claude SPEEG-SCHATZ         
Sub-Investigator: Tristan BOURCIER         
Sub-Investigator: David GAUCHER         
Sub-Investigator: Laurent BALLONZOLI         
Sub-Investigator: Arnaud SAUER         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01768078     History of Changes
Other Study ID Numbers: Creuzot-Garcher PHRC IR 2007
Study First Received: January 8, 2013
Last Updated: January 14, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Endophthalmitis
Eye Diseases
Eye Infections
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014