NCT02337972

Brief Summary

The aim of this study is to investigate the conjunctival bacterial flora and antibiotic resistance patterns following serial intravitreal injections of anti-VEGF in diabetic patients, using a povidone-iodine preparation without preinjection or postinjection topical antibiotics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

11 months

First QC Date

January 1, 2015

Last Update Submit

February 19, 2015

Conditions

Diabetic RetinopathyDiabetic Macular Edema

Keywords

diabetic macular edemaIntravitreal injectionconjunctival flora

Outcome Measures

Primary Outcomes (1)

  • Change of conjunctival flora and bacterial resistance

    4 month

Study Arms (1)

Diabetic patients

EXPERIMENTAL

Patients with Diabetes Mellitus and macular edema who were determined by their treating physician to require at least 3 serial injections with an anti-Vascular epithelial growth factor (VEGF). Prior to each injection a use of povidone-iodine 4% drops will be performed to clean the conjunctival sac

Drug: povidone-iodine 4%

Interventions

povidone-iodine 4%DRUG

Prior to each injection and before the use of povidone-iodine drops, a conjunctival culture will be taken

Also known as: Wokadine, Pyodine
Diabetic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age above 18
  • patients with diabetes mellitus
  • patients with diabetic macular edema

You may not qualify if:

  • patients who had received a prior intraocular injection in either eye,
  • current use of contact lenses,
  • chronic use of any ophthalmic medication,
  • ocular surgery within the past 6 months,
  • use of systemic antibiotics within the past 6 months,
  • known allergy or contraindication to povidone-iodine or proparacaine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Non-US Resident, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Irit Barequet, MD

    Sheba medical center, Ophthalmology department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irit Barequet, MD

CONTACT

972-52-8305302ibarequet@yahoo.com

Adi Einan-Lifshitz, MD

CONTACT

972-50-5191213adi.einan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of cornea unit, Ophthalmology department

Study Record Dates

First Submitted

January 1, 2015

First Posted

January 14, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

IL(1)