- ICH GCP
- Registr klinických studií v USA
- Klinická 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Studijní místa
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Texas
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Fort Worth, Texas, Spojené státy, 76134
- Call Alcon Call Center for Trial Locations
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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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Experimentální: 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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Aktivní komparátor: Lucentis + sham
Expansion: Ranibizumab 0.5 mg administered as monthly IVT injections in 1 eye (study eye) with interim sham injections, for 24 weeks
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Fake injection used for masking purposes
IVT injection
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Mean change from baseline in best corrected visual acuity (BCVA) at Day 85
Časové okno: Baseline, Day 85
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Baseline, Day 85
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Percentage of LMG324-treated subjects with no identified SoC treatment need up to and including Day 85
Časové okno: Up to Day 85
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Up to Day 85
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Best Corrected Visual Acuity (BCVA)
Časové okno: Up to Day 169
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Up to Day 169
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Central subfield thickness total (CSFTtot)
Časové okno: Up to Day 169
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Up to Day 169
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Central subfield thickness neuro-retina (CFSTnr)
Časové okno: Up to Day 169
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Up to Day 169
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Lesion thickness
Časové okno: Up to Day 169
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Up to Day 169
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Subretinal fluid with foveal involvement (SRFfi) thickness
Časové okno: Up to Day 169
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Up to Day 169
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Retinal pigment epithelial detachment with foveal involvement (PEDfi) thickness
Časové okno: Up to Day 169
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Up to Day 169
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Area of lesion (associated with CNV)
Časové okno: Up to Day 169
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Up to Day 169
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Area of CNV within a lesion
Časové okno: Up to Day 169
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Up to Day 169
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Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Časové okno: Up to Day 169
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Up to Day 169
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Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Časové okno: Up to Day 169
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Up to Day 169
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Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration (AUC0-t)
Časové okno: Up to Day 169
|
Up to Day 169
|
Maximum observed maximum plasma concentration (Cmax)
Časové okno: Up to Day 169
|
Up to Day 169
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Time to reach the maximum observed plasma concentration (Tmax)
Časové okno: Up to Day 169
|
Up to Day 169
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Observed maximum plasma concentration following drug administration, by dose (Cmax/D)
Časové okno: Up to Day 169
|
Up to Day 169
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Area under the plasma concentration-time curve divided by dose (AUC/D)
Časové okno: Up to Day 169
|
Up to Day 169
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Frequency of subjects with anti-LMG324 antibodies
Časové okno: Up to Day 169
|
Up to Day 169
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Clinical Scientist I, NIBR, Alcon Research
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- LMG324-2201
- 2014-005214-37 (Číslo EudraCT)
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