- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02870803
OCT-angiography in Diabetic Patients
21. april 2017 opdateret af: Retina Clinic, Sao Paulo, Brazil
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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
20
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Gabriel Andrade, M.D.
- Telefonnummer: (11) 3058-2020
- E-mail: drgabrielandrade@gmail.com
Undersøgelse Kontakt Backup
- Navn: Guilherme Lima, M.D.
- Telefonnummer: (11) 3058-2020
- E-mail: guilherme.lima@retina.com.br
Studiesteder
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São Paulo, Brasilien, 06010-130
- Rekruttering
- Retina Clinic
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Kontakt:
- Paula D Silva
- Telefonnummer: 05511989906751
- E-mail: paula.silva@retina.com.br
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Kontakt:
- Daniela R Rubin
- Telefonnummer: (+11) 3056-0000
- E-mail: daniela.rubin@retina.com.br
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Ledende efterforsker:
- Gabriel C Andrade, M.D.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients with diabetic macular edema.
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
OCT-angiography qualitative changes
Tidsramme: 12 months
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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
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: André Maia, M.D., Retina Clinic CEO
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Klein R, Klein BE, Moss SE. Visual impairment in diabetes. Ophthalmology. 1984 Jan;91(1):1-9.
- Kiri 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.
- Puliafito 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.
- Knudsen 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.
- Ozdek 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.
- Otani 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2016
Primær færdiggørelse (Forventet)
1. november 2017
Studieafslutning (Forventet)
1. april 2018
Datoer for studieregistrering
Først indsendt
14. august 2016
Først indsendt, der opfyldte QC-kriterier
14. august 2016
Først opslået (Skøn)
17. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Retina Clinic / OCT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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