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Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion (UWFARVO)

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ClinicalTrials.gov Identifier: NCT04075695
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Changzheng Chen, Renmin Hospital of Wuhan University

Tracking Information
First Submitted Date August 29, 2019
First Posted Date September 3, 2019
Last Update Posted Date October 28, 2019
Actual Study Start Date September 18, 2019
Estimated Primary Completion Date August 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2019)
Change in non-perfused areas in different retinal area [ Time Frame: Baseline and1,2,3,6,9and 12 months ]
Change in non-perfused areas in different retinal area from Baseline to 1,2,3,6,9and 12 months
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 24, 2019)
  • Change in best corrected visual acuity [ Time Frame: Baseline and1,2, 3, 6, 9 and 12 months ]
    Change in best corrected visual acuity from Baseline to 1,2,3,6,9and 12 months
  • Change in central macular thickness [ Time Frame: Baseline and1,2, 3, 6, 9 and 12 months ]
    Change in central macular thickness from Baseline to 1,2,3,6,9and 12 months
Original Secondary Outcome Measures
 (submitted: August 30, 2019)
  • Change in best corrected visual acuity [ Time Frame: Baseline and1,2, 3, 4,6, 9 and 12 months ]
    Change in best corrected visual acuity from Baseline to 1,2,3,6,9and 12 months
  • Change in center macular thickness [ Time Frame: Baseline and1,2, 3, 4,6, 9 and 12 months ]
    Change in center macular thickness from Baseline to 1,2,3,6,9and 12 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
Official Title Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
Brief Summary The changes of ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion by ultra-wide field fluorescence angiography (UWFA)
Detailed Description In this study, the ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion will be evaluated by ultra-wide field fluorescence angiography (UWFA). UWFA has a wider range than conventional angiography, and can clearly observe the peripheral retina. The purpose of this study is to quantitatively analyze these changes and investigate the effect on macular edema and neovascularization secondary to retinal vein occlusion.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Chinese
Condition Retinal Vein Occlusion
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 30, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 12, 2021
Estimated Primary Completion Date August 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Male or female aged 18 years or more
  2. Patients with a diagnosis of CRVO,BRVO or HRVO without macular edema
  3. Duration of RVO not more than 4 months
  4. Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) which completely resolved (normalization of visual acuity and fundus examination) and who experienced a recurrence of RVO are also considered naive
  5. Patient who agrees to participate to the study and who has given his/her written, informed consent

Exclusion Criteria:

  1. Patient with another retinal disease in the study eye: diabetic retinopathy, maculopathy of any cause (age-related macular degeneration, epimacular membrane, myopia, etc) responsible for decreased vision, advanced glaucoma, cataract severely affecting vision and/or requiring surgical treatment during the 24 months study period
  2. Active or suspected ocular or periocular infection
  3. Active severe intraocular inflammation
  4. RVO complicated with neovascularization
  5. Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye
  6. Patient already included in the study for the treatment of the fellow eye
  7. Pregnant or breastfeeding woman
  8. Lack of effective contraception for women of childbearing age
  9. Patient taking part in an interventional study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: CZ Chen, PHD +86 13072765173 whuchenchzh@163.com
Contact: XL Wang +86 13117192316 wangxl0807@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04075695
Other Study ID Numbers UWFARVO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Changzheng Chen, Renmin Hospital of Wuhan University
Study Sponsor Renmin Hospital of Wuhan University
Collaborators Not Provided
Investigators
Principal Investigator: Renmin Hospital of Wuhan University Renmin Hospital of Wuhan University
PRS Account Renmin Hospital of Wuhan University
Verification Date October 2019