Diabetic Macular EdemaNCT02870803
OCT-angiography in Diabetic Patients
An observational study of Diabetic Macular Edema, run by Retina Clinic, Sao Paulo, Brazil at 1 site in Brazil.
Trial summary
Around the world there is an increasing incidence of diabetes mellitus, with millions of people affected. In this population, diabetic macular edema (DME) is the most common cause of visual impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Apr 2018
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with diabetic macular edema.
Who may be able to join
- Previous diagnosis of diabetes mellitus type 1 or 2;
- Age equal or greater than 18 years;
- At least one eye with diabetic macular edema and central thickness greater than or equal to 290 microns (female patients) or 305 microns (males) measured by OCT and subjected to intravitreal pharmacotherapy.
Who cannot join
- Aphakic patients;
- History of major eye surgeries (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery) in the last 4 months;
- Tractional retinal detachment involving the macula, vitreomacular traction syndrome or other concurrent macular diseases;
- Advanced or uncontrolled glaucoma (according to the investigator's judgment); Evidence of angle neovascularization;
- Presence of an eye condition (besides diabetic retinopathy) which, in the opinion of the investigator, may alter the visual acuity during the study course (e.g. venous or arterial retinal occlusions, uveitis or other ocular inflammatory diseases, neovascular glaucoma, etc.);
- Significative cataract which, in the opinion of the investigator, may be decreasing visual acuity in 3 lines or more;
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- History of YAG Laser capsulotomy in the last 2 months;
- Severe renal disease, defined as chronic renal failure requiring dialysis or a kidney transplant;
- Blood pressure higher than 180/110 mmHg, acute myocardial infarction, other acute cardiac events requiring hospitalisation, stroke, transient ischemic attack or treatment for congestive heart failure;
- Systemic treatment with anti-VEGF or pro-VEGF in the last 4 months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Retina Clinic
São Paulo, 06010-130
Paula D Silva, 05511989906751, paula.silva@retina.com.br
Daniela R Rubin, (+11) 3056-0000, daniela.rubin@retina.com.br
About this study
Official title: OCT-angiography in Diabetic Patients: Qualitative Changes of the Intermediate and Deep Capillary Plexuses After Resolution of Macular Edema by Intravitreal Pharmacotherapy
Around the world there is an increasing incidence of diabetes mellitus, with millions of people affected. In this population, diabetic macular edema (DME) is the most common cause of visual impairment. While the visual impairment caused by EMD is variable, its early treatment can improve visual acuity and quality of life. The objective of this project is to use the new OCT-angiography technology, which evaluates macular capillary network without the need of intravenous injection of contrast, to assess macular microcirculatory network in its response to intravitreal pharmacological treatment of EMD. The resulting qualitative evaluation can be helpful in understanding the pathophysiology of visual loss associated with DME and in determining prognosis.
Read the detailed description
Patients who participate in this study will be selected among adults treated at the Retina Clinic and Ocular Oftalmologia clinics and will be aware of all stages of the research, formalizing the approval of their participation by informed consent term. The tests will be performed after pupillary dilation with 2 eye drops of tropicamide 1% (Mydriacyl, Alcon Laboratories), in Cirrus 5000 HD-OCT devices (Carl Zeiss Meditec - Dublin USA). Image acquisition protocols Optic Disc Cube 200x200 and 512x128 Macular Cube will be used, with analysis by RNFL protocols and NGO Analysis Report and Macular Cube Analysis Report, respectively. Subjective analysis of the examinations will be performed by the three authors of this project independently and then compared between them.
- Conditions
- Diabetic Macular Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT-angiography qualitative changes
Assess the OCT-angiography qualitative changes observed in intermediate and deep capillary networks in diabetic patients after the resolution of macular edema with intravitreal drug treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Clinic, Sao Paulo, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Maia, M.D., Study chair, Retina Clinic CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870803
- Sponsor's protocol ID
- Retina Clinic / OCT
- Status last verified
- Apr 2017
- First submitted
- 14 Aug 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Klein R, Klein BE, Moss SE. Visual impairment in diabetes. Ophthalmology. 1984 Jan;91(1):1-9.
PubMed 6709312Kiri A, Dyer DS, Bressler NM, Bressler SB, Schachat AP. Detection of diabetic macular edema: Nidek 3Dx stereophotography compared with fundus biomicroscopy. Am J Ophthalmol. 1996 Nov;122(5):654-62. doi: 10.1016/s0002-9394(14)70483-0.
PubMed 8909204Puliafito CA, Hee MR, Lin CP, Reichel E, Schuman JS, Duker JS, Izatt JA, Swanson EA, Fujimoto JG. Imaging of macular diseases with optical coherence tomography. Ophthalmology. 1995 Feb;102(2):217-29. doi: 10.1016/s0161-6420(95)31032-9.
PubMed 7862410Knudsen ST, Bek T, Poulsen PL, Hove MN, Rehling M, Mogensen CE. Macular edema reflects generalized vascular hyperpermeability in type 2 diabetic patients with retinopathy. Diabetes Care. 2002 Dec;25(12):2328-34. doi: 10.2337/diacare.25.12.2328.
PubMed 12453981Ozdek SC, Erdinc MA, Gurelik G, Aydin B, Bahceci U, Hasanreisoglu B. Optical coherence tomographic assessment of diabetic macular edema: comparison with fluorescein angiographic and clinical findings. Ophthalmologica. 2005 Mar-Apr;219(2):86-92. doi: 10.1159/000083266.
PubMed 15802932Otani T, Kishi S. Correlation between optical coherence tomography and fluorescein angiography findings in diabetic macular edema. Ophthalmology. 2007 Jan;114(1):104-7. doi: 10.1016/j.ophtha.2006.06.044. Epub 2006 Oct 27.
PubMed 17070586
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT-angiography in Diabetic Patients: Qualitative Changes of the Intermediate and Deep Capillary Plexuses After Resolution of Macular Edema by Intravitreal Pharmacotherapy
- ClinicalTrials.gov ID
- NCT02870803
- Acronym / sponsor ID
- Retina Clinic / OCT
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Retina Clinic, Sao Paulo, BrazilUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 17 Aug 2016 (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.
Around the world there is an increasing incidence of diabetes mellitus, with millions of people affected. In this population, diabetic macular edema (DME) is the most common cause of visual impairment. While the visual impairment caused by EMD is variable, its early treatment can improve visual acuity and quality of life. The objective of this project is to use the new OCT-angiography technology, which evaluates macular capillary network without the need of intravenous injection of contrast, to assess macular microcirculatory network in its response to intravitreal pharmacological treatment of EMD. The resulting qualitative evaluation can be helpful in understanding the pathophysiology of visual loss associated with DME and in determining prognosis.
Detailed description
Patients who participate in this study will be selected among adults treated at the Retina Clinic and Ocular Oftalmologia clinics and will be aware of all stages of the research, formalizing the approval of their participation by informed consent term. The tests will be performed after pupillary dilation with 2 eye drops of tropicamide 1% (Mydriacyl, Alcon Laboratories), in Cirrus 5000 HD-OCT devices (Carl Zeiss Meditec - Dublin USA). Image acquisition protocols Optic Disc Cube 200x200 and 512x128 Macular Cube will be used, with analysis by RNFL protocols and NGO Analysis Report and Macular Cube Analysis Report, respectively. Subjective analysis of the examinations will be performed by the three authors of this project independently and then compared between them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetic macular edema.
Key inclusion criteria (3 listed)
- Previous diagnosis of diabetes mellitus type 1 or 2;
- Age equal or greater than 18 years;
- At least one eye with diabetic macular edema and central thickness greater than or equal to 290 microns (female patients) or 305 microns (males) measured by OCT and subjected to intravitreal pharmacotherapy.
Key exclusion criteria (10 listed)
- Aphakic patients;
- History of major eye surgeries (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery) in the last 4 months;
- Tractional retinal detachment involving the macula, vitreomacular traction syndrome or other concurrent macular diseases;
- Advanced or uncontrolled glaucoma (according to the investigator's judgment); Evidence of angle neovascularization;
- Presence of an eye condition (besides diabetic retinopathy) which, in the opinion of the investigator, may alter the visual acuity during the study course (e.g. venous or arterial retinal occlusions, uveitis or other ocular inflammatory diseases, neovascular glaucoma, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OCT-angiography qualitative changes
Time frame: 12 months
Assess the OCT-angiography qualitative changes observed in intermediate and deep capillary networks in diabetic patients after the resolution of macular edema with intravitreal drug treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Results publication: PubMed 6709312Klein R, Klein BE, Moss SE. Visual impairment in diabetes. Ophthalmology. 1984 Jan;91(1):1-9.
- Results publication: PubMed 8909204Kiri A, Dyer DS, Bressler NM, Bressler SB, Schachat AP. Detection of diabetic macular edema: Nidek 3Dx stereophotography compared with fundus biomicroscopy. Am J Ophthalmol. 1996 Nov;122(5):654-62. doi: 10.1016/s0002-9394(14)70483-0.
- Results publication: PubMed 7862410Puliafito CA, Hee MR, Lin CP, Reichel E, Schuman JS, Duker JS, Izatt JA, Swanson EA, Fujimoto JG. Imaging of macular diseases with optical coherence tomography. Ophthalmology. 1995 Feb;102(2):217-29. doi: 10.1016/s0161-6420(95)31032-9.
- Results publication: PubMed 12453981Knudsen ST, Bek T, Poulsen PL, Hove MN, Rehling M, Mogensen CE. Macular edema reflects generalized vascular hyperpermeability in type 2 diabetic patients with retinopathy. Diabetes Care. 2002 Dec;25(12):2328-34. doi: 10.2337/diacare.25.12.2328.
- Results publication: PubMed 15802932Ozdek SC, Erdinc MA, Gurelik G, Aydin B, Bahceci U, Hasanreisoglu B. Optical coherence tomographic assessment of diabetic macular edema: comparison with fluorescein angiographic and clinical findings. Ophthalmologica. 2005 Mar-Apr;219(2):86-92. doi: 10.1159/000083266.
- Results publication: PubMed 17070586Otani T, Kishi S. Correlation between optical coherence tomography and fluorescein angiography findings in diabetic macular edema. Ophthalmology. 2007 Jan;114(1):104-7. doi: 10.1016/j.ophtha.2006.06.044. Epub 2006 Oct 27.
- Individual participant dataSharing planned: No
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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.
André Maia, M.D. study chair
Retina Clinic CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Retina Clinic, Sao Paulo, Brazil 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 10 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Andrade, M.D. ((11) 3058-2020, drgabrielandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT-angiography qualitative changes (time frame: 12 months). 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 NCT02870803, which also lists 6 linked publications.
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 25 Apr 2017.