Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-related Macular Degeneration
13. april 2012 oppdatert av: Lpath, Inc.
A Phase 1, Dose-Escalating, Multi-Center, Study of iSONEP (Sonepcizumab [LT1009]) Administered as an Intravitreal Injection to Subjects With Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is a disease that, in time, destroys the macula, which is the central part of the retina that gives sharp central vision.
The primary purpose of this study is to assess the safety of iSONEP which is a humanized monoclonal antibody against a bioactive lipid, sphingosine 1-phosphate (S1P).
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
S1P modulates the AMD-associated processes of angiogenesis, inflammation and fibrosis.
A potential strategy for treating choroidal neovascularization associated with AMD is to reduce the biologically available extracellular levels of S1P.
iSONEP is highly selective for S1P and binds with picomolar affinity.
Lpath proposes that iSONEP would deprive many cell types (fibroblasts, pericytes, vascular endothelial cells and inflammatory) of important growth and survival factors thus targeting the multiple maladaptive processes of exudative AMD that ultimately result in the loss of photoreceptors, their supporting cells, and visual acuity.
Targeting simultaneously multiple components of the choroidal neovascular response is a novel approach and has the potential to be more potent than "single-targeted" therapeutics such as anti-VEGF therapies.
Studietype
Intervensjonell
Registrering (Faktiske)
15
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85014
- Retinal Consultants of Arizona, LTD
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Florida
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Winter Haven, Florida, Forente stater, 33880
- Center for Retina and Macular Disease
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Indiana
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Indianapolis, Indiana, Forente stater, 46280
- Midwest Eye Institute
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Michigan
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Grand Rapids, Michigan, Forente stater, 49525
- Vitreo-Retinal Consultants
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Wills Eye Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 50 years and older
- BCVA ETDRS letter score in study eye between 20-57 letters using ETDRS refraction (Snellen of 20/70-20/400)
- Any CNV secondary to AMD in study eye, classic, minimally classic or occult with leakage on fluorescein angiography and intraretinal or subretinal fluid on OCT
- Visual acuity in fellow eye must be 20/800 or better at 4 meters
- Able to read, understand and sign the consent form before entering into study
Exclusion Criteria:
- Ocular disease other than CNV that could compromise vision in study eye
- Systemic immunosuppressive medication/therapy (e.g., chemotherapy, steroids)
- Uncontrolled hypertension and/or arrhythmias
- QT/QTc interval measurement >450 msec
- Cancer within the last 2 years except superficial basal or squamous cell skin cancer or cervical carcinoma in situ
- Have angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>8 diopters) or CNV secondary to other causes than AMD
- Any additional ocular diseases which have irreversibly compromised visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema and severe non-proliferative diabetic retinopathy
- Any intraocular or general surgery, including cataract surgery, within 2 months of Day 1
- History of uveitis in either eye
- Any ocular or periocular infection within 4 weeks prior to Day 1
- Active ocular inflammation grade trace and above
- Cup to disc ratio >0.8, IOP >21 mmHg in glaucoma subjects treated with more than 2 ocular hypotensive agents
- Previous pars plana vitrectomy or trabeculectomy in study eye
- History of anterior vitrectomy
- Inability to obtain photographs, FA or OCT to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access
- Aphakia
- Previous intravitreal Macugen, Avastin or Lucentis (injection or drug device implantation) in study eye within 6 weeks or triamcinolone within 6 months
- Receiving or requiring chronic concomitant therapy with systemic anti-angiogenic treatments p.o., parenteral (excluding inhaled steroids) (>5 mg) or topical corticosteroids in the study eye
- PDT within 12 weeks prior to Day 1
- Subjects taking systemic anticoagulants such as warfarin
- Investigational agents or devices within 6 weeks prior to Day 1
- Females who are pregnant or nursing and women of child bearing potential who are not using adequate contraceptive precautions
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 1
iSONEP
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single intravitreal injection of 0.2, 0.6, 1.0, 1.4 or 1.8 mg/eye
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To determine safety, tolerability, maximum tolerated dose and dose-limiting toxicity of iSONEP following a single intravitreal injection to subjects with choroidal neovascularization secondary to AMD
Tidsramme: Active phase: 30 days post-injection; Follow-up phase: 12 months post-injection
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Active phase: 30 days post-injection; Follow-up phase: 12 months post-injection
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To characterize systemic pharmacokinetics, evaluate the immunogenicity, and investigate preliminary efficacy on retinal lesion thickness determined by OCT; size and extent of CNV and lesion area; and visual acuity
Tidsramme: Active phase: 30 days post-injection; Follow-up phase: 12 months post-injection
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Active phase: 30 days post-injection; Follow-up phase: 12 months post-injection
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Glenn Stoller, MD, Lpath, Inc.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Visentin B, Vekich JA, Sibbald BJ, Cavalli AL, Moreno KM, Matteo RG, Garland WA, Lu Y, Yu S, Hall HS, Kundra V, Mills GB, Sabbadini RA. Validation of an anti-sphingosine-1-phosphate antibody as a potential therapeutic in reducing growth, invasion, and angiogenesis in multiple tumor lineages. Cancer Cell. 2006 Mar;9(3):225-38. doi: 10.1016/j.ccr.2006.02.023.
- Caballero S, Swaney J, Moreno K, Afzal A, Kielczewski J, Stoller G, Cavalli A, Garland W, Hansen G, Sabbadini R, Grant MB. Anti-sphingosine-1-phosphate monoclonal antibodies inhibit angiogenesis and sub-retinal fibrosis in a murine model of laser-induced choroidal neovascularization. Exp Eye Res. 2009 Mar;88(3):367-77. doi: 10.1016/j.exer.2008.07.012. Epub 2008 Aug 6.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2008
Primær fullføring (Faktiske)
1. juli 2010
Studiet fullført (Forventet)
1. august 2012
Datoer for studieregistrering
Først innsendt
2. oktober 2008
Først innsendt som oppfylte QC-kriteriene
6. oktober 2008
Først lagt ut (Anslag)
7. oktober 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. april 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. april 2012
Sist bekreftet
1. april 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LT1009-Oph-001
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Kliniske studier på iSONEP
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Lpath, Inc.PfizerAvsluttet
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Lpath, Inc.FullførtEksudativ aldersrelatert makuladegenerasjonForente stater