Safety and Efficacy of Double Staining With Brilliant Blu... | NCT01820520

Studies
Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery

NCT01820520

Sponsor

Asociación para Evitar la Ceguera en México

Status

Terminated

Last Update Posted

May 30, 2024Actual

Enrollment

22Actual

Phase

Phase 3

Conditions

Macular Hole
Epiretinal Membrane

Interventions

brilliant blue G

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Undefined

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Mar 26, 2013

First Submission Date that Met QC Criteria

Mar 27, 2013

First Posted Date

Mar 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2024

Last Update Posted Date

May 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Double staining with brilliant blue G during vitrectomy	Experimental		Drug: brilliant blue G

Interventions

Name	Type	Description	Arm Group Labels	Other Names
brilliant blue G	Drug	Double staining with brilliant blue G 0.025% for macular surgery	Double staining with brilliant blue G during vitrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Visual acuity	Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart	6 months
Complications	Presence of any ocular complication

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Diagnosis of glaucoma
Known allergy to brilliant blue G

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asociación para Evitar la Ceguera en México		Mexico City	Mexico City	04030	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D012167	Retinal Perforations
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C004692	coomassie Brilliant Blue

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided