NCT01820520

Brief Summary

Study designed to evaluate the safety and efficacy of double staining with brilliant blue G 0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography, pattern reversal electroretinogram and multifocal electroretinogram.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

March 26, 2013

Last Update Submit

May 29, 2024

Conditions

Macular HoleEpiretinal Membrane

Outcome Measures

Primary Outcomes (3)

  • Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography

    Average thickness of ganglion cell layer - inner plexiform layer measured by spectral domain optical coherence tomography

    6 months

  • Amplitude of pattern reversal electroretinogram

    Amplitude of pattern reversal electroretinogram (in microvolts)

    6 months

  • Amplitude of b-wave of multifocal electroretinogram

    Measurement of the amplitude of the b-wave of multifocal electroretinogram

    6 months

Secondary Outcomes (2)

  • Visual acuity

    6 months

  • Complications

    6 months

Study Arms (1)

Double staining with brilliant blue G during vitrectomy

EXPERIMENTAL
Drug: brilliant blue G

Interventions

brilliant blue GDRUG

Double staining with brilliant blue G 0.025% for macular surgery

Double staining with brilliant blue G during vitrectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age 18 years of older
  • Signing of informed consent
  • Macular pathology requiring vitrectomy (epiretinal membrane, macular hole, vitreomacular traction syndrome)

You may not qualify if:

  • Diagnosis of glaucoma
  • Known allergy to brilliant blue G

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación para Evitar la Ceguera en México

Mexico City, Mexico City, 04030, Mexico

Location

MeSH Terms

Conditions

Retinal PerforationsEpiretinal Membrane

Interventions

coomassie Brilliant Blue

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2013

First Posted

March 28, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(1)