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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 septembre 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

373

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Expérimental: TE Ranibizumab 0.5 mg alone
Patients received ranibizumab intravitreal injection therapy only.
Médicament: 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.
Comparateur actif: PRN Ranibizumab 0.5 mg
Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novartis Pharmaceuticals

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2010

Achèvement primaire (Réel)

1 avril 2013

Achèvement de l'étude (Réel)

1 avril 2013

Dates d'inscription aux études

Première soumission

27 juillet 2010

Première soumission répondant aux critères de contrôle qualité

27 juillet 2010

Première publication (Estimation)

29 juillet 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

15 septembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 septembre 2014

Dernière vérification

1 septembre 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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