- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01042678
Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema
14. april 2014 opdateret af: Allergan
A Phase I/II, Open-label, Single Ascending Dose Study Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetics of Intravitreal MP0112 in Patients With Diabetic Macular Edema (DME)
The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with diabetic retinal edema.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
18
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Wilmer Eye Institute
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Ophthalmic Consultants of Boston
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Texas
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Austin, Texas, Forenede Stater, 78705
- Retina Research Center
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Houston, Texas, Forenede Stater, 77030
- Retina Consultants of Houston
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female age 18 years or older
- Macular edema due to diabetic retinopathy
- Best-corrected visual acuity in the study eye of 20/40 to 20/400
- Central subfield thickness ≥ 250 microns by OCT
- Females of childbearing potential must have a negative serum pregnancy test at Screening
- Male subjects must or be: 1) surgically sterilized for at least 6 months, or 2) use an appropriate method of barrier contraception (e.g., condoms with spermicide) and advise any sexual partner of child-bearing potential that she must also use a reliable method of contraception (e.g., hormonal contraceptive, intrauterine device, diaphragm with spermicide) during the study and for 30 days from study drug administration.
- Ability to understand the nature of the study and give written informed consent
- Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
Exclusion Criteria:
- Any indication of irreversible vision loss such as significant atrophy, scarring, fibrosis, or hyperpigmentation in the fovea
- Presence of significant ocular abnormalities in the study eye that prevent retinal assessment, including media opacities, cataract, or inadequate papillary dilation
- Presence of vision loss from another ocular disease other than DME
- History of any intraocular surgery within 3 months of Baseline
- History of intraocular injection of anti-VEGF agent or steroids within 3 months of Baseline
- History of laser photocoagulation for macular edema within 4 months prior to Baseline
- Uncontrolled hypertension > 140 systolic or > 95 diastolic
- HbA1C ≥ 12%
- Creatinine: > 1.5 x upper limit of normal (ULN)
- Alanine transaminase (ALT), aspartate transaminase (AST), and gamma-glutamyl transferase (GGT): > ULN
- White blood cells (WBC), hematocrit, and platelets: < lower limit of normal (LLN)
- Heart rate < 60 beats per minute (bpm) or history of clinically significant bradycardia
- History of human immunodeficiency virus (HIV), chronic hepatitis B, or chronic hepatitis C infections
- Subjects with infections requiring hospitalization and/or antibiotic treatment 14 days prior to Baseline
- Subjects with any medical condition that in the judgment of the investigator could poise unacceptable risk to the subject or compromise interpretation of the data to be collected
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: MP0112 (0,04 mg)
Enkelt 0,04 mg intravitreal injektion af MP0112 i undersøgelsesøjet.
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Single intravitreal injection of MP0112 in the study eye
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Eksperimentel: MP0112 (0,15 mg)
Enkelt 0,15 mg intravitreal injektion af MP0112 i undersøgelsesøjet.
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Single intravitreal injection of MP0112 in the study eye
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Eksperimentel: MP0112 (0,4 mg)
Enkelt 0,4 mg intravitreal injektion af MP0112 i undersøgelsesøjet.
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Single intravitreal injection of MP0112 in the study eye
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Eksperimentel: MP0112 (1,0 mg)
Enkelt 1,0 mg intravitreal injektion af MP0112 i undersøgelsesøjet.
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Single intravitreal injection of MP0112 in the study eye
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Eksperimentel: MP0112 (2,0 mg)
Enkelt 2,0 mg intravitreal injektion af MP0112 i undersøgelsesøjet.
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Single intravitreal injection of MP0112 in the study eye
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Eksperimentel: MP0112 (3,6 mg)
Enkelt 3,6 mg intravitreal injektion af MP0112 i undersøgelsesøjet.
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Single intravitreal injection of MP0112 in the study eye
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Tidsramme: 16 weeks
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Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events.
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Preexisting conditions that worsened during the study were reported as adverse events.
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16 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Antal deltagere med positivt bindende anti-MP0112-antistoffer
Tidsramme: 12 uger
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Blodprøver blev udtaget før behandling (basislinje) og uge 4, 8 og 12.
Prøver blev analyseret for anti-MP0112-antistoffer under anvendelse af et enzymbundet immunosorbent-assay.
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12 uger
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Best-Corrected Visual Acuity (BCVA)
Tidsramme: Baseline, Week 16
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BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 16.
The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
The higher the letters read correctly on the eye chart the better the vision.
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Baseline, Week 16
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Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)
Tidsramme: Baseline, Week 16
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Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16.
A negative change from Baseline indicated improvement (less foveal thickness).
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Baseline, Week 16
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Serum Levels of MP0112
Tidsramme: 16 Weeks
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Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16.
Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis.
Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.
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16 Weeks
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Aqueous Humor Levels of MP0112
Tidsramme: 1 Week
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Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis.
Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.
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1 Week
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2010
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. december 2010
Datoer for studieregistrering
Først indsendt
1. januar 2010
Først indsendt, der opfyldte QC-kriterier
4. januar 2010
Først opslået (Skøn)
5. januar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MP0112-CP02
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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