- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02956330
Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201
Retrospective Study of the Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept for the Treatment of Macular Edema Associated With RVO in Subjects Who Completed Parent Study CLS1003-201
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
This is a non-interventional, retrospective study of up to 6 months for subjects that completed the parent study CLS1003-201. This study is designed to collect data from patients following their parent study exit visit, through either the time of the next treatment for RVO or at least 6 months following the parent study exit visit, whichever occurs first.
During this non-interventional retrospective study, the following data will be collected in an online questionnaire (or where required, on paper) provided by Clearside:
- Next RVO therapy administered (if applicable), including reason for treatment
- Continued documentation of current or changes in medical or ocular conditions following parent study
- Concomitant drug or therapy changes
- Visual acuity, including details on the method used in the assessment
- Central retinal thickness, including details on the equipment used in its determination
- Intraocular pressure, including details on the equipment used in its determination
Subjects will be selected based on parent study primary investigator's access to their medical records access, following exit from CLS1003-201. Data will also be collected on the total number of patients included in this non interventional study as well as reasons patients were excluded. Data will be summarized from the randomization treatment assignment in the parent study.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Texas
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San Antonio, Texas, Vereinigte Staaten
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Completed enrollment and did not receive additional aflibercept therapy in the Parent study, CLS1003-201
Exclusion Criteria:
- N/A
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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CLS1003-201
Those subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Time to additional therapy for RVO
Zeitfenster: 6 months following exit from Parent study
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6 months following exit from Parent study
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mean change from baseline for intraocular pressure
Zeitfenster: 6 months following exit from Parent study
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Measured by applanation tonometry
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6 months following exit from Parent study
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Mean change from baseline in central subfield thickness
Zeitfenster: 6 months following exit from Parent study
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Based on spectral domain optical coherence tomography
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6 months following exit from Parent study
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Mean change from baseline in best corrected visual acuity
Zeitfenster: 6 months following exit from Parent study
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Based on ETDRS
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6 months following exit from Parent study
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Thomas Ciulla, MD, Clearside Biomedical, Inc.
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
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CLS1003-202
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