- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Texas
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San Antonio, Texas, 미국
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Completed enrollment and did not receive additional aflibercept therapy in the Parent study, CLS1003-201
Exclusion Criteria:
- N/A
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Time to additional therapy for RVO
기간: 6 months following exit from Parent study
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6 months following exit from Parent study
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean change from baseline for intraocular pressure
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Thomas Ciulla, MD, Clearside Biomedical, Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .