Clinical trial

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

NCT01820520

Name

RE11-09

Description

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 arms

Trial start

2013-01-01

Estimated PCD

2014-02-01

Trial end

2014-02-01

Status

Terminated

Phase

Early phase I

Treatment

brilliant blue G

Double staining with brilliant blue G 0.025% for macular surgery

Arms:

Double staining with brilliant blue G during vitrectomy

Size

Primary endpoint

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

6 months

Amplitude of pattern reversal electroretinogram

6 months

Amplitude of b-wave of multifocal electroretinogram

6 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

Updated at

2024-05-30

1 organization

1 product

2 indications

Organization

Asociación para Evitar la Ceguera en México

Product

Brilliant Blue G

Indication

Macular Hole

Indication

Epiretinal Membrane