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Microperimetry and Optical Coherence Tomography (OCT) With Lucentis for Diabetic Macular Edema (DME) (MORE)

Microperimetry and High-Definition-OCT in Ranibizumab Treatment for Diabetic Macular Edema (MORE-Study)

Diabetic maculopathy is the leading cause of visual impairment in the working-age population in developed countries. Diabetic macular edema can cause impaired visual acuity and so far is treated by laser, vitreous surgery, and intravitreal cortisone application. Still 50% of the cases do not respond to the treatment.

Recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis) in diabetic macular edema has proven efficacy to last over a period of 3 to 6 months. Still, the optimal dosage for those intravitreal injections still has to be found, because frequent injections are necessary.

The measurement of visual acuity is inadequate to quantify in detail the visual impairment. Using the newest technology of a high-definition optical coherence tomography (Cirrus-OCT, Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a miroperimetry (MP-1, Nidek Technologies) to determine retinal sensitivity, we hope to find the optimal dosage of intravitreal anti-VEGF treatment in diabetic macular edema.

Study objective: To determine the dose response of 0.5mg and 1.0mg ranibizumab (Lucentis®, Novartis Pharma) intravitreal injection in subjects with resistant diabetic macular edema and evaluate safety and tolerability.

Studienübersicht

Status

Unbekannt

Intervention / Behandlung

Detaillierte Beschreibung

Diabetic maculopathy due to diabetic macular edema (DME) is the leading cause of visual impairment in the working-age population in developed countries. DME is the swelling of the retina resulting from the exudation and accumulation of extracellular fluid and proteins in the macula. Structural changes in the endothelium of retinal vessels lead to a breakdown of the blood-retina barrier and increase vascular permeability, resulting in exudation. The standardized treatment of DME is a focal laser or GRID-laser treatment with or without combined triamcinolone intravitreal injections. Those laser treatments produce scars in the central retina and are not always very effective. In cases of macular traction or taut posterior hyloid vitrectomy and retinal surgery are necessary.

Vascular endothelial growth factor (VEGF) has been implicated as an important factor in the occurrence of vascular permeability in DME. In patients with DME, VEGF levels are significantly elevated, compared to patients without ocular disease. Therefore, anti-VEGF treatment has been implicated as an important treatment of DME and recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis Pharma) in diabetic macular edema has proven to be very effective. Just like in patients with age-related macular degeneration (AMD), anti-VEGF treatment was given 3 times every 4-6 weeks. The same treatment was repeated at a relapse of the disease, again 3 times every 4-6 weeks. One study group treated DME with 0.5mg ranibizumab intravitreal injections and the other compared 0.3mg to 0.5mg of ranibizumab intravitreal injections. An optimal treatment dose has not been found yet.

Visual acuity assessment is currently used to determine the functional damage caused by edema, although it may not completely describe the functional condition of the patient. Furthermore, visual acuity alone does not seem to be the best parameter to define the effect and continuation of treatment. Retinal thickness, as measured by the noninvasive optical coherence tomography (OCT) can deliver detailed information about the retinal situation during and after treatment. Also a fundus related perimetry, known as microperimetry (MP), is a useful noninvasive examination method in determining the site of relative and absolute scotomas and also fixation characteristics. With MP the macular sensitivity can be measured to further assess the macular condition.

Using the newest technology of a high-definition OCT (Cirrus-OCT, Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a MP with automated correction for eye movements (MP-1, Nidek Technologies) to determine retinal sensitivity, we intend to analyze this new treatment option for DME, and find the optimized dose for intravitreal injection of ranibizumab in cases of ineffective laser treatment.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

40

Phase

  • Phase 2
  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Vienna, Österreich, 1030
        • Rudolf Foundation Clinic

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

51 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Study eye with clinically significant macular edema, for which one of the following characteristics has to be present:
  • retinal thickening at or within 500µm from the center of the macula,
  • hard exudates at or within 500µm from the center of the macula associated with thickening of the adjacent retina,
  • a zone (>1-disk area) or zones of retinal thickening of which any part is within 1 disk diameter from the center of the macula.
  • Second line treatment after ineffective laser treatment
  • Men or women with diabetes mellitus
  • Only one eye per patient
  • Age > 50 years
  • HbA1c < 8%

Exclusion Criteria:

  • Study eye with concomitant retinal or choroidal disorder other than diabetic retinopathy
  • Study eye with significant central lens opacities and / or conditions that limit the view of the fundus
  • poor general condition
  • woman of childbearing potential, current pregnancy or breastfeeding
  • Patients who are unwilling to adhere to visit examination schedules
  • Evidence of macular traction or taut posterior hyloid.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 0.5 mg Ranibizumab
3 intravitreal injections of 0.5 mg Ranibizumab every 5 weeks
3 intravitreal injection every 5 weeks
Andere Namen:
  • Lucentis
Experimental: 1.0 mg of Ranibizumab
3 intravitreal injections of 1.0mg Ranibizumab every 5 weeks
3 intravitreal injection every 5 weeks
Andere Namen:
  • Lucentis

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Retinal thickness
Zeitfenster: at 3 months
at 3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Retinal sensitivity
Zeitfenster: 3, 6, and 9 months
3, 6, and 9 months
Distance best corrected visual acuity
Zeitfenster: 3, 6, and 9 months
3, 6, and 9 months
Reading best corrected visual acuity
Zeitfenster: 3, 6, and 9 months
3, 6, and 9 months
Intraocular pressure
Zeitfenster: 3, 6, and 9 months
3, 6, and 9 months
Type of diabetic macular edema
Zeitfenster: 3, 6, and 9 months
3, 6, and 9 months
Type of diabetes mellitus HbA1c
Zeitfenster: 3, 6, and 9 months
3, 6, and 9 months
Blood-pressure
Zeitfenster: 3, 6, and 9 months
3, 6, and 9 months
Age
Zeitfenster: 3, 6, and 9 months
3, 6, and 9 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Ulrike Stolba, MD, Department of Ophthalmology, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery, Rudolf Foundation Clinic

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2008

Primärer Abschluss (Tatsächlich)

1. Mai 2011

Studienabschluss (Voraussichtlich)

1. Mai 2012

Studienanmeldedaten

Zuerst eingereicht

20. April 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. April 2009

Zuerst gepostet (Schätzen)

22. April 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

27. Juni 2011

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juni 2011

Zuletzt verifiziert

1. Juni 2011

Mehr Informationen

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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