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Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus (RETAIN)

10. September 2014 aktualisiert von: Novartis Pharmaceuticals

A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus

The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

373

Phase

  • Phase 3

Kontakte und Standorte

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

Studienorte

  • Belgien
      • Gent, Belgien, 9000
        • Novartis Investigative Site
      • Kortrijk, Belgien, 8500
        • Novartis Investigative Site
      • Leuven, Belgien, 3000
        • Novartis Investigative Site
  • Frankreich
      • Bordeaux, Frankreich, 33 000
        • Novartis Investigative Site
      • Dijon, Frankreich, 21034
        • Novartis Investigative Site
      • Lille, Frankreich, 59 037
        • Novartis Investigative Site
      • Limoges Cedex, Frankreich, 87042
        • Novartis Investigative Site
      • Lyon, Frankreich, 69003
        • Novartis Investigative Site
      • Nantes Cedex 1, Frankreich, 44093
        • Novartis Investigative Site
      • Nice, Frankreich, 6 000
        • Novartis Investigative Site
      • Paris, Frankreich, 75015
        • Novartis Investigative Site
      • Paris cedex 10, Frankreich, 75475
        • Novartis Investigative Site
  • Griechenland
      • Athens, Griechenland, 152 31
        • Novartis Investigative Site
      • Thessaloniki, Griechenland, 546 36
        • Novartis Investigative Site
    • Crete
      • Heraklion Crete, Crete, Griechenland, GR-71110
        • Novartis Investigative Site
  • Irland
      • Dublin, Irland
        • Novartis Investigative Site
      • Dublin 7, Irland
        • Novartis Investigative Site
      • Kilkenny, Irland
        • Novartis Investigative Site
      • Limerick, Irland
        • Novartis Investigative Site
  • Italien
    • FI
      • Firenze, FI, Italien, 50134
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italien, 20132
        • Novartis Investigative Site
      • Milano, MI, Italien, 20122
        • Novartis Investigative Site
      • Milano, MI, Italien, 20157
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italien, 00133
        • Novartis Investigative Site
      • Roma, RM, Italien, 00198
        • Novartis Investigative Site
  • Niederlande
      • Amsterdam, Niederlande, 1081 HV
        • Novartis Investigative Site
      • Amsterdam, Niederlande, 1105 AZ
        • Novartis Investigative Site
      • Leiden 2333 ZA, Niederlande, 2333
        • Novartis Investigative Site
      • Nijmegen, Niederlande, 6525 EX
        • Novartis Investigative Site
      • Rotterdam, Niederlande, 3011 BH
        • Novartis Investigative Site
  • Polen
      • Bielsko-Biala, Polen, 43-300
        • Novartis Investigative Site
      • Lublin, Polen, 20-954
        • Novartis Investigative Site
      • Warszawa, Polen, 00-416
        • Novartis Investigative Site
      • Wroclaw, Polen, 50-367
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3000-354
        • Novartis Investigative Site
      • Lisboa, Portugal, 1150-199
        • Novartis Investigative Site
      • Porto, Portugal, 4099-001
        • Novartis Investigative Site
  • Schweiz
      • Bern, Schweiz, 3010
        • Novartis Investigative Site
      • Bern, Schweiz, 3012
        • Novartis Investigative Site
      • Binningen, Schweiz, 4102
        • Novartis Investigative Site
      • Zürich, Schweiz, 8063
        • Novartis Investigative Site
  • Spanien
      • Las Palmas de Gran Canaria, Spanien, 35016
        • Novartis Investigative Site
      • Madrid, Spanien, 28040
        • Novartis Investigative Site
    • Andalucia
      • Málaga, Andalucia, Spanien, 29010
        • Novartis Investigative Site
    • Castilla y Leon
      • Valladolid, Castilla y Leon, Spanien, 47011
        • Novartis Investigative Site
    • Cataluña
      • L'Hospitalet de Llobregat, Cataluña, Spanien, 08907
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spanien, 03016
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spanien, 46015
        • Novartis Investigative Site
    • Galicia
      • Santiago de Compostela, Galicia, Spanien, 15705
        • Novartis Investigative Site
  • Tschechische Republik
      • Hradec Kralove, Tschechische Republik, 505 05
        • Novartis Investigative Site
      • Olomouc, Tschechische Republik, 775 20
        • Novartis Investigative Site
      • Plzen, Tschechische Republik, 301 00
        • Novartis Investigative Site
      • Prague 2, Tschechische Republik, 128 08
        • Novartis Investigative Site
      • Praha 6, Tschechische Republik, 169 02
        • Novartis Investigative Site
  • Ungarn
      • Budapest, Ungarn, 1083
        • Novartis Investigative Site
      • Budapest, Ungarn, 1133
        • Novartis Investigative Site
      • Debrecen, Ungarn, 4012
        • Novartis Investigative Site
      • Gyor, Ungarn, 9024
        • Novartis Investigative Site
  • Vereinigtes Königreich
      • Aberdeen, Vereinigtes Königreich, AB25 2ZN
        • Novartis Investigative Site
      • Bristol, Vereinigtes Königreich, BS1 2LX
        • Novartis Investigative Site
      • Leeds, Vereinigtes Königreich, LS9 7TF
        • Novartis Investigative Site
      • Manchester, Vereinigtes Königreich, M13 9WL
        • Novartis Investigative Site
      • Newcastle Upon Tyne, Vereinigtes Königreich, NE1 4LP
        • Novartis Investigative Site
      • Sheffield, Vereinigtes Königreich, S10 2JF
        • Novartis Investigative Site
      • Southampton, Vereinigtes Königreich, SO16 6YD
        • Novartis Investigative Site
      • Sunderland, Vereinigtes Königreich, SR2 9HP
        • Novartis Investigative Site
      • Wolverhampton, Vereinigtes Königreich, WV10 0QP
        • Novartis Investigative Site
    • Surrey
      • Frimley, Surrey, Vereinigtes Königreich, GU16 7UJ
        • Novartis Investigative Site

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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

Patient

  • Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization [WHO] guidelines) with glycosylated hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must have been stable for at least 3 month.

Ocular

  • Patients with visual impairment due to DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye.
  • BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening.
  • Concomitant conditions in the study eye are only permitted if, in the opinion of the investigator, they do not prevent improvement of visual acuity on study treatment.

Exclusion Criteria:

Patient Compliance/ Administrative

  • Pregnant or nursing (lactating) women.

Ocular medical history

  • Active intraocular inflammation (grade trace or above) in either eye at enrollment.
  • Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrollment.
  • History of uveitis in either eye at any time.
  • Structural damage within 0.5 disc diameter of the center of the macular in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
  • Uncontrolled glaucoma in either eye at screening.

Prior Ocular treatments

  • Panretinal laser photocoagulation in the study eye within 6 months prior to randomization.
  • Focal/grid laser photocoagulation in the study eye within 3 months prior to randomization.
  • Treatment with anti-angiogenic drugs in either eye.

Systemic conditions or treatments

  • History of stroke within 6 months prior to enrollment.
  • Renal failure requiring dialysis.
  • Untreated diabetes mellitus.
  • Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg.

Other protocol-defined inclusion/exclusion criteria may apply

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: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: TE Ranibizumab 0.5 mg and Laser
On Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections. Laser therapy was applied at Day 1. It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months. Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection.
Arzneimittel: Ranibizumab
Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
Experimental: TE Ranibizumab 0.5 mg alone
Patients received ranibizumab intravitreal injection therapy only.
Arzneimittel: Ranibizumab
Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
Aktiver Komparator: PRN Ranibizumab 0.5 mg
Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Arzneimittel: Ranibizumab
Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Zeitfenster: Baseline to Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline to Month 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Zeitfenster: Baseline to Month 24
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline to Month 24
Visual Acuity of the Study Eye: Change From Baseline at Month 12
Zeitfenster: Baseline and Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline and Month 12
Visual Acuity of the Study Eye: Change From Baseline at Month 24
Zeitfenster: Baseline and Month 24
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline and Month 24
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Zeitfenster: Baseline, Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline, Month 12
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Zeitfenster: Baseline, 24 month
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Baseline, 24 month
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12
Zeitfenster: Baseline, Month 12
High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Baseline, Month 12
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24
Zeitfenster: Baseline and 24 month
High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Baseline and 24 month
Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24
Zeitfenster: Baseline, Month 12 and Month 24
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning
Baseline, Month 12 and Month 24
EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24
Zeitfenster: Baseline, Month 12 and Month 24
The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= "no problems", 2="some problems" and 3="extreme problems" . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction
Baseline, Month 12 and Month 24

Mitarbeiter und Ermittler

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

Sponsor

Novartis Pharmaceuticals

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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. September 2010

Primärer Abschluss (Tatsächlich)

1. April 2013

Studienabschluss (Tatsächlich)

1. April 2013

Studienanmeldedaten

Zuerst eingereicht

27. Juli 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juli 2010

Zuerst gepostet (Schätzen)

29. Juli 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. September 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. September 2014

Zuletzt verifiziert

1. September 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CRFB002D2304
  • 2010-019795-74 (EudraCT-Nummer)

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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