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Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201

19. december 2019 opdateret af: Clearside Biomedical, Inc.

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

The purpose of this non interventional retrospective study is to continue to collect data from patients following their completion of Protocol CLS 1003-201: "Safety and Efficacy of Suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Macular Edema Following Retinal Vein Occlusion" (ie, the parent study).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Texas
  - San Antonio, Texas, Forenede Stater

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will include approximately 30 adult subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201.

Beskrivelse

Inclusion Criteria:

Completed enrollment and did not receive additional aflibercept therapy in the Parent study, CLS1003-201

Exclusion Criteria:

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
CLS1003-201 Those subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Time to additional therapy for RVO Tidsramme: 6 months following exit from Parent study	6 months following exit from Parent study

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Mean change from baseline for intraocular pressure Tidsramme: 6 months following exit from Parent study	Measured by applanation tonometry	6 months following exit from Parent study
Mean change from baseline in central subfield thickness Tidsramme: 6 months following exit from Parent study	Based on spectral domain optical coherence tomography	6 months following exit from Parent study
Mean change from baseline in best corrected visual acuity Tidsramme: 6 months following exit from Parent study	Based on ETDRS	6 months following exit from Parent study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Clearside Biomedical, Inc.

Efterforskere

Studieleder: Thomas Ciulla, MD, Clearside Biomedical, Inc.

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. november 2016

Primær færdiggørelse (Faktiske)

12. april 2017

Studieafslutning (Faktiske)

12. april 2017

Datoer for studieregistrering

Først indsendt

3. november 2016

Først indsendt, der opfyldte QC-kriterier