Epiretinal MembranePhase 3NCT01627977
Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
A Phase 3 study testing Dye of Lutein, Zeaxanthin and Brilliant Blue in people with Epiretinal Membrane and Macular Hole, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin and brilliant blue to stain the internal limiting membrane as well as the epiretinal membranes during the Vitrectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Epiretinal Membrane, Macular Hole, Proliferative Diabetic Retinopathy
- What is being tested?
- Dye of Lutein, Zeaxanthin and Brilliant Blue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Mar 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
- Patients over 18 years, both gender
- Diagnosis of epiretinal membrane OR macular hole OR proliferative diabetic retinopathy
- Indication of surgical treatment for removal of the epiretinal membrane
Who cannot join
- Any history of eye disease
- glaucoma
- Eye infection affecting any structure provided eye
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Depto. of Ophthalmology - Hospital São Paulo - UNIFESP
São Paulo, São Paulo, 04023-062
About this study
Official title: A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin and brilliant blue to stain the internal limiting membrane as well as the epiretinal membranes during the Vitrectomy surgery.
Read the detailed description
Twenty five patients with epiretinal membrane, macular hole or proliferative diabetic retinopathy and indication of vitrectomy surgery will be selected to participate in this study.
- Being tested
- Dye of Lutein, Zeaxanthin and Brilliant Blue
- Keywords
- chromovitrectomy, epiretinal membrane
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dye of Lutein, Zeaxanthin and Brilliant BlueOther
Also called lutein, zeaxanthin, brilliant blue
dye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes
| Study group | Role | What they receive |
|---|---|---|
| Dye of Lutein/Zeaxanthin/Brilliant Blue | Experimental | during the surgery will be evaluated if the dye is suitable for dyeing the internal limiting membrane as well as the epiretinal membrane Receives: Other: Dye of Lutein, Zeaxanthin and Brilliant Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility of the membrane after injection of the dye
The visibility of the membrane after injection of the dye should be graduated by the physician as Bad, OR Fair, OR Good, OR Very Good
Measured: during the surgery
Secondary outcomes (2)
Degree of impregnation of the dye
The degree of impregnation of the membrane by the dye should be graduated according to the following scale:(0)not flushed; (1)stained weakly (light green); (2)moderately stained (medium green); (3)stained intensely (dark green)
Measured: during the surgery
Usefulness of the dye
the physician should evaluate the usefulness of the dye, according to the following scale: Bad, Fair, Good, Very Good
Measured: at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epiretinal MembraneStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Belfort Jr., Federal University of São Paulo
- Investigators
- Rubens Belfort, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627977
- Sponsor's protocol ID
- LUT-RET
- Status last verified
- Mar 2016
- First submitted
- 22 Jun 2012
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: data published: Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8.
Publications
Badaro E, Furlani B, Prazeres J, Maia M, Lima AA, Souza-Martins D, Muccioli C, Lucatto LF, Belfort R Jr. Soluble lutein in combination with brilliant blue as a new dye for chromovitrectomy. Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8. doi: 10.1007/s00417-013-2539-5. Epub 2014 Jan 19.
PubMed 24441951
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
- ClinicalTrials.gov ID
- NCT01627977
- Acronym / sponsor ID
- LUT-RET
- Keywords
- chromovitrectomy, epiretinal membrane
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Jun 2012 (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.
The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin and brilliant blue to stain the internal limiting membrane as well as the epiretinal membranes during the Vitrectomy surgery.
Detailed description
Twenty five patients with epiretinal membrane, macular hole or proliferative diabetic retinopathy and indication of vitrectomy surgery will be selected to participate in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dye of Lutein/Zeaxanthin/Brilliant Blue | Experimental | Other: Dye of Lutein, Zeaxanthin and Brilliant Blueduring the surgery will be evaluated if the dye is suitable for dyeing the internal limiting membrane as well as the epiretinal membrane |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years, both gender
- Diagnosis of epiretinal membrane OR macular hole OR proliferative diabetic retinopathy
- Indication of surgical treatment for removal of the epiretinal membrane
Key exclusion criteria (3 listed)
- Any history of eye disease
- glaucoma
- Eye infection affecting any structure provided eye
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 |
|---|---|---|
| Dye of Lutein, Zeaxanthin and Brilliant BlueAlso: lutein, zeaxanthin, brilliant bluedye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes | Other | Dye of Lutein/Zeaxanthin/Brilliant Blue |
Primary outcome
Visibility of the membrane after injection of the dye
Time frame: during the surgery
The visibility of the membrane after injection of the dye should be graduated by the physician as Bad, OR Fair, OR Good, OR Very Good
2 secondary outcomes
Degree of impregnation of the dye
Time frame: during the surgery
Usefulness of the dye
Time frame: at the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Derived from this study: PubMed 24441951Badaro E, Furlani B, Prazeres J, Maia M, Lima AA, Souza-Martins D, Muccioli C, Lucatto LF, Belfort R Jr. Soluble lutein in combination with brilliant blue as a new dye for chromovitrectomy. Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8. doi: 10.1007/s00417-013-2539-5. Epub 2014 Jan 19.
- Individual participant dataSharing planned: Yes. data published: Graefes Arch Clin Exp Ophthalmol. 2014 Jul;252(7):1071-8.
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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.
Rubens Belfort, MD principal investigator
Federal University of São Paulo
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 Dye of Lutein, Zeaxanthin and Brilliant Blue in people with Epiretinal Membrane and Macular Hole, run by Federal University of São Paulo at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 16 Mar 2016. 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 Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visibility of the membrane after injection of the dye (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01627977, which also lists 1 linked publication.
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 16 Mar 2016.