- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02448446
The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates
The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Foveal Involving Edema and Lipid Exudates
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
Consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm.
The patients will be randomized to 1 of 2 treatment groups. Group 1: Treatment algorithm based on the Diabetic Retinopathy Clinical Research (DRCR) protocol I 4:2:7 strategy based on the presence of macular edema.
Group 2: Continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved.
Sample size: 30 eyes Follow-up Schedule: Every 4 weeks throughout the study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
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California
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Huntington Beach, California, Vereinigte Staaten, 92647
- South Coast Retina Center; Carson, McBeath, Boswell, Inc
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Long Beach, California, Vereinigte Staaten, 90505
- South Coast Retina Center; Carson, McBeath, and Boswell, Inc
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Santa Monica, California, Vereinigte Staaten, 90404
- Retina Partners
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Torrance, California, Vereinigte Staaten, 90505
- South Coast Retina Center; Carson, McBeath, Boswell, Inc
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Subjects will be eligible if the following criteria are met:
Inclusion Criteria
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age ≥ 18 years
- Type 1 or Type 2 Diabetes mellitus
- Best corrected ETDRS visual acuity (20/32-20/320) or letter score 78 to 24
- Diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss
- Retinal thickness measured on spectral domain optical coherence tomography (OCT). Zeiss Cirrus: ≥290μm in women and ≥305 μm in men in the central subfield. Heidelberg Spectralis: ≥305μm in women and ≥320 μm in men in the central subfield
- Lipid exudates involving the central subfield on spectral domain OCT.
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
- Treatment for diabetic macular edema within the prior 4 months.
- Panretinal photocoagulation within the prior 4 months or anticipated need for panretinal photocoagulation within the next 6 months
- major ocular surgery within the prior 4 months
- myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack, or treatment for acute congestive heart failure occurred within 4 months before randomization
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Diabetic macular edema treatment group (Group 1)
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
|
intravitreally administered
Andere Namen:
|
Aktiver Komparator: Diabetic macular edema and lipid treatment group (Group 2)
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
|
intravitreally administered
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
Zeitfenster: 6-12 months
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Compare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters.
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6-12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Zeitfenster: 12 months
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12 months
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Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Zeitfenster: 12 months
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12 months
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Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography
Zeitfenster: 12 months
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12 months
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Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Zeitfenster: 12 months
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12 months
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Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography
Zeitfenster: 12 months
|
12 months
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Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Zeitfenster: 12 months
|
12 months
|
Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability
Zeitfenster: 12 months
|
12 months
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Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability
Zeitfenster: 12 months
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12 months
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
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
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ML259577
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