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

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ClinicalTrials.gov Identifier: NCT02956330
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Brief Summary:
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).

Condition or disease
Macular Edema Retinal Vein Occlusion

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : November 2016
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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



Primary Outcome Measures :
  1. Time to additional therapy for RVO [ Time Frame: 6 months following exit from Parent study ]

Secondary Outcome Measures :
  1. Mean change from baseline for intraocular pressure [ Time Frame: 6 months following exit from Parent study ]
    Measured by applanation tonometry

  2. Mean change from baseline in central subfield thickness [ Time Frame: 6 months following exit from Parent study ]
    Based on spectral domain optical coherence tomography

  3. Mean change from baseline in best corrected visual acuity [ Time Frame: 6 months following exit from Parent study ]
    Based on ETDRS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956330


Locations
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United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
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Study Director: Jennifer Kissner, PhD Clearside Biomedical, Inc.

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Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02956330     History of Changes
Other Study ID Numbers: CLS1003-202
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Keywords provided by Clearside Biomedical, Inc.:
RVO
ME
Central Subfield Thickness
OCT
Optical Coherence Tomography
Cystoid Macular Edema
Subretinal Fluid
Eylea
Aflibercept
Anti-VEGF
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases