Macular HolePhase 3NCT01820520
Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
A Phase 3 study testing brilliant blue G in people with Macular Hole and Epiretinal Membrane, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Macular Hole, Epiretinal Membrane
- What is being tested?
- brilliant blue G
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2013to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age 18 years of older
- Signing of informed consent
- Macular pathology requiring vitrectomy (epiretinal membrane, macular hole, vitreomacular traction syndrome)
Who cannot join
- Diagnosis of glaucoma
- Known allergy to brilliant blue G
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en México
Mexico City, Mexico City, 04030
About this study
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.
- Conditions
- Macular Hole, Epiretinal Membrane
- Being tested
- brilliant blue G
- Medical subject headings
- Retinal Perforations, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brilliant blue GDrug
Double staining with brilliant blue G 0.025% for macular surgery
| Study group | Role | What they receive |
|---|---|---|
| Double staining with brilliant blue G during vitrectomy | Experimental | Not described Receives: Drug: brilliant blue G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Amplitude of pattern reversal electroretinogram
Amplitude of pattern reversal electroretinogram (in microvolts)
Measured: 6 months
Amplitude of b-wave of multifocal electroretinogram
Measurement of the amplitude of the b-wave of multifocal electroretinogram
Measured: 6 months
Secondary outcomes (2)
Visual acuity
Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart
Measured: 6 months
Complications
Presence of any ocular complication
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Undefined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820520
- Sponsor's protocol ID
- RE11-09
- Status last verified
- May 2024
- First submitted
- 26 Mar 2013
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
- ClinicalTrials.gov ID
- NCT01820520
- Acronym / sponsor ID
- RE11-09
- Conditions
- Macular Hole, Epiretinal Membrane
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Undefined
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double staining with brilliant blue G during vitrectomy | Experimental | Drug: brilliant blue G |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age 18 years of older
- Signing of informed consent
- Macular pathology requiring vitrectomy (epiretinal membrane, macular hole, vitreomacular traction syndrome)
Key exclusion criteria (2 listed)
- Diagnosis of glaucoma
- Known allergy to brilliant blue G
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brilliant blue GDouble staining with brilliant blue G 0.025% for macular surgery | Drug | Double staining with brilliant blue G during vitrectomy |
Primary outcome
Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography
Time frame: 6 months
Average thickness of ganglion cell layer - inner plexiform layer measured by spectral domain optical coherence tomography
Amplitude of pattern reversal electroretinogram
Time frame: 6 months
Amplitude of pattern reversal electroretinogram (in microvolts)
Amplitude of b-wave of multifocal electroretinogram
Time frame: 6 months
Measurement of the amplitude of the b-wave of multifocal electroretinogram
2 secondary outcomes
Visual acuity
Time frame: 6 months
Complications
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Undefined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing brilliant blue G in people with Macular Hole and Epiretinal Membrane, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Undefined). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.