- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02398500
Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Related Macular Degeneration
An Open-label Single Ascending Dose and Randomized Double-Masked, Ranibizumab Controlled, Safety, Tolerability, and Efficacy Study of Intravitreal LMG324 in Subjects With Neovascular Age-Related Macular Degeneration
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The study will start with a single dose ascending (SAD) phase. LMG324 will be administered on Day 1 with no further treatment until implementation of standard of care (SoC) therapy. SoC therapy is ranibizumab 0.5 mg administered per label. Dose groups will be implemented sequentially to allow for safety review between the current and subsequent dose group. All treatments will be open-label, including ranibizumab used as SoC therapy.
In the enrollment expansion phase, subjects randomized to LMG324 arm will receive a single LMG324 IVT injection on Day 1 followed by sham (fake) IVT injections until implementation of SoC therapy. After implementation, SoC therapy will be applied monthly with sham injections applied at the interim planned visits. The enrollment expansion phase may start at a selected dose level whilst the dose escalation phase is still ongoing.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
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Texas
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Fort Worth, Texas, Vereinigte Staaten, 76134
- Call Alcon Call Center for Trial Locations
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Must give written informed consent, be able to make the required study visits and follow instructions.
- Best corrected visual acuity (BCVA) of 34 letters (approximately 20/200 Snellen or better) in the non-study eye.
SAD population only:
- Subject's study eye must have a choroidal neovascularization (CNV) lesion due to age-related macular degeneration (AMD), either treatment naïve or previously treated, that can be expected to benefit, in the opinion of the investigator, from anti-vascular endothelial growth factor (anti-VEGF) therapy.
- Previously treated eyes must have a history of least 3 administrations of any intravitreal (IVT) anti-VEGF therapeutic for the treatment of CNV with the last injection administered ≥ 1 month prior to the planned administration of the study drug.
Enrollment expansion population only
- Subject's study eye must have untreated and active CNV lesion due to AMD.
- BCVA, between 73 - 23 letters, inclusive (approximate Snellen equivalent 20/40 - 20/320) in the study eye.
Exclusion Criteria:
SAD and enrollment expansion population
- Both eyes: any active ocular or periocular infection or active intraocular inflammation (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis).
- Study eye: current vitreous hemorrhage or a history of rhegmatogenous retinal detachment.
- Study eye: uncontrolled glaucoma (intraocular pressure [IOP] >25 mmHg on medication or according to Investigator's judgment).
SAD population only
- Presence of any contraindications, in the Investigator's opinion, to IVT anti-VEGF therapeutic administration.
Enrollment expansion population only
- Study eye: subject has received any approved or investigational treatment for exudative (wet) AMD other than vitamin supplements.
- Study eye: any current or history of macular or retinal disease other than exudative AMD
- Study eye: serous pigment epithelial detachment (PED) under the foveal center or retinal pigment epithelium (RPE) tear/rip.
- Study eye: any concurrent intraocular condition (eg, cataract, diabetic retinopathy) that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study.
- Study eye: other ocular diseases that, in the opinion of the Investigator, can compromise the visual acuity
- Study eye: Surgery, as specified in the protocol.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: LMG324
SAD: LMG324 administered as a single IVT injection in 1 eye (study eye) in 1 of 4 doses, with 15-day follow-up
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IVT injection
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Experimental: LMG324 + sham
Expansion: LMG324 administered as a single IVT injection in 1 eye (study eye), followed by sham injections, until implementation of SoC therapy as specified in the protocol, for 24 weeks
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IVT injection
Fake injection used for masking purposes
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Aktiver Komparator: Lucentis + sham
Expansion: Ranibizumab 0.5 mg administered as monthly IVT injections in 1 eye (study eye) with interim sham injections, for 24 weeks
|
Fake injection used for masking purposes
IVT injection
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Mean change from baseline in best corrected visual acuity (BCVA) at Day 85
Zeitfenster: Baseline, Day 85
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Baseline, Day 85
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Percentage of LMG324-treated subjects with no identified SoC treatment need up to and including Day 85
Zeitfenster: Up to Day 85
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Up to Day 85
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Best Corrected Visual Acuity (BCVA)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Central subfield thickness total (CSFTtot)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Central subfield thickness neuro-retina (CFSTnr)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Lesion thickness
Zeitfenster: Up to Day 169
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Up to Day 169
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Subretinal fluid with foveal involvement (SRFfi) thickness
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Retinal pigment epithelial detachment with foveal involvement (PEDfi) thickness
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Area of lesion (associated with CNV)
Zeitfenster: Up to Day 169
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Up to Day 169
|
Area of CNV within a lesion
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration (AUC0-t)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Maximum observed maximum plasma concentration (Cmax)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Time to reach the maximum observed plasma concentration (Tmax)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Observed maximum plasma concentration following drug administration, by dose (Cmax/D)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Area under the plasma concentration-time curve divided by dose (AUC/D)
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Frequency of subjects with anti-LMG324 antibodies
Zeitfenster: Up to Day 169
|
Up to Day 169
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Clinical Scientist I, NIBR, Alcon Research
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LMG324-2201
- 2014-005214-37 (EudraCT-Nummer)
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