- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01226628
A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration
1 août 2017 mis à jour par: Janssen Research & Development, LLC
Phase 1/2a, Multicenter, Randomized, Dose Escalation, Fellow-Eye Controlled, Study Evaluating the Safety and Clinical Response of a Single, Subretinal Administration of Human Umbilical Tissue-Derived Cells (CNTO 2476) in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age-related Macular Degeneration
The main purpose of this study to evaluate the safety and tolerability of CNTO 2476 administered subretinally (beneath the retina) using the iTrack Model 275 micro catheter in patients with visual acuity (acuteness or clearness of vision) impairment associated with the geographic atrophy (GA: partial or complete wasting away of retinal layer below the retina) manifestation of age-related macular degeneration (AMD: medical condition which usually affects older adults and results in a loss of vision in the center of the visual field [the macula] because of damage to the retina).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The study is a Phase 1/2a, multicenter, randomized (the study medication is assigned by chance), single dose, dose escalation, fellow-eye controlled study evaluating the safety and clinical response of a single, subretinal administration of CNTO 2476 in patients with visual acuity impairment associated with GA secondary to AMD.
The study will consist of screening (up to 21 days prior to treatment) period, treatment (Day 1) period and follow up period.
The study will be conducted in 2 portions: the Phase 1 portion will include dose escalation and the Phase 2 portion will enroll additional patients randomized to one of the 2 optimal doses selected from the Phase 1 portion (with an acceptable safety profile seen in Phase 1).
For Phase 1, the treatment eye will be the eye with worse visual acuity or the one chosen by the investigator, however, the treatment eye cannot have a visual acuity no better than 20/200.
For Phase 2a, the treatment eye will be the eye with worse visual acuity, and cannot have a visual acuity better than 20/80.
Approximately 30 patients will participate in the Phase 1 dose escalation portion, and 38 patients will be enrolled in the Phase 2a portion (19 patients receiving optimal dose level X from Phase 1 and 19 receiving optimal dose level Y from Phase 1).
In the Phase 1 portion, treatment will be assigned 5 sequential cohorts, with 3 patients per cohort in each of the first 4 cohorts and 6 patients in the fifth cohort.
Cohort A patients will be treated first, followed by Cohort B patients.
All patients in a given cohort must have completed at least 4 weeks of post-treatment follow-up before patients in the next cohort may be treated.
Follow-up will include postoperative follow-up period of 12 months (Day 2, Day 7, Day 15, Week 3, Week 4, Months 2, 3, 6, and 12) and long-term safety follow-up period (patients will be evaluated every 6 months for safety assessments).
Safety assessments will include vital signs, AEs, and concomitant medications and routine 12-lead electrocardiograms (ECG).
The anticipated study duration will be approximately 5 years (1 year in the 12-month postoperative follow-up period; up to 4 years in the long-term safety follow-up period).
Type d'étude
Interventionnel
Inscription (Réel)
39
Phase
- Phase 2
- La phase 1
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
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California
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Arcadia, California, États-Unis
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis
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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
50 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Women must be incapable of childbearing
- Patient must be a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures
- Confirmed diagnosis of bilateral geographic atrophy (GA) of the macula bilaterally caused by age-related macular degeneration
Exclusion Criteria:
- Evidence of exudative ("wet") age -related macular degeneration in either eye
- Evidence of other significant ophthalmologic disease (eg, glaucoma)
- Ocular hypertension
- Previous cell therapy other than blood components
- Previous treatment for age-related macular degeneration (AMD) other than antioxidant or zinc supplements or other oral vitamin supplements
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: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Cohort A
Phase 1: 3 patients will receive 60,000 human umbilical tissue-derived cells (hUTC)
|
Autres noms:
CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment.
During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
|
Expérimental: Cohort B
Phase 1: 3 patients will receive 120,000 hUTC
|
Autres noms:
CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment.
During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
|
Expérimental: Cohort C
Phase 1: 3 patients will receive 300,000 hUTC
|
Autres noms:
CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment.
During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
|
Expérimental: Cohort D
Phase 1: 3 patients will receive 560,000 hUTC
|
Autres noms:
CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment.
During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
|
Expérimental: Cohort E
Phase 1: 6 patients will receive 300,000 hUTC
|
Autres noms:
CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment.
During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
|
Expérimental: Cohort F
Phase 1: 6 patients will receive either 60,000 or 300,000 hUTC
|
Autres noms:
CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment.
During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
|
Expérimental: Cohort G
Phase 1: 6 patients will receive either 60,000 or 300,000 hUTC
|
Autres noms:
CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment.
During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
|
Expérimental: Phase 2a
Up to 38 patients will receive one of two optimal doses as selected from the Phase 1 portion of the study
|
Autres noms:
CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment.
During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of eyes with serious ocular adverse events occurring over the first 12 months of the study
Délai: 12 months
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This number will be summarized descriptively for treated and fellow eyes within each dose level included in Phase 1 and Phase 2a portions of the study
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from baseline in antibody peak values
Délai: Baseline (Screening), up to 60 months
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Baseline (Screening), up to 60 months
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Yearly rate of increase from baseline in area of Geographic Atrophy (GA)
Délai: Baseline (Screening), up to 60 months
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Baseline (Screening), up to 60 months
|
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Changes from baseline in visual function
Délai: Baseline (Screening), up to 60 months
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Changes from baseline in visual function is measured as changes in best corrected visual acuity [BCVA], low luminance BCVA, low luminance deficit, reading speed, contrast threshold, visual field and retinal thickness measured by spectral-domain optical coherence tomography (SD-OCT) at registered sections of the macula that include the geographic atrophy and adjacent retina
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Baseline (Screening), up to 60 months
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Change from baseline in Visual Functioning Questionnaire (VFQ)-25
Délai: Baseline (Screening), up to 60 months
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The VFQ-25 is a reliable and validated 25-item version of the larger 51-item National Eye Institute Visual Function Questionnaire.
The questionnaire must be administered by the study staff and must not be self-administered.
Analysis of VFQ-25 questionnaire data will be based on the thirteen sub-scales and a composite score.
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Baseline (Screening), up to 60 months
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Incidence of adverse events
Délai: up to 60 months
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Incidence of adverse events will be assessed in both Phases (Phase 1 and Phase 2a)
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up to 60 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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 (Réel)
21 octobre 2010
Achèvement primaire (Réel)
31 mars 2015
Achèvement de l'étude (Réel)
31 mai 2017
Dates d'inscription aux études
Première soumission
21 octobre 2010
Première soumission répondant aux critères de contrôle qualité
21 octobre 2010
Première publication (Estimation)
22 octobre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 août 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 août 2017
Dernière vérification
1 août 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR017548
- CNTO2476MDG1002 (Autre identifiant: Janssen Research & Development, LLC)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .
Essais cliniques sur CNTO 2476
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Janssen Pharmaceutical K.K.RetiréDégénérescence maculaire | Atrophie géographique | Acuité visuelleJapon
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Janssen Research & Development, LLCComplétéDégénérescence maculaire | Atrophie géographique | Acuité visuelleÉtats-Unis
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Centocor, Inc.RésiliéRétinite pigmentaireÉtats-Unis
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Janssen-Cilag International NVComplété
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Centocor Research & Development, Inc.ComplétéLupus érythémateux systémique | Lupus érythémateux cutané
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Janssen Inc.ComplétéPsoriasisÉtats-Unis, Pologne, Canada, Belgique, Allemagne
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Centocor, Inc.Complété
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Janssen Pharmaceutical K.K.Complété
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Janssen Research & Development, LLCComplétéInfarctus | Ischémie | Accident vasculaire cérébralÉtats-Unis
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Janssen Research & Development, LLCComplétéEn bonne santé | Asthme | La dermatite atopiqueAllemagne, Belgique