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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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)

Condition or disease
Retinal Vein Occlusion

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : August 12, 2020
Estimated Study Completion Date : August 12, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fluorescein




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:   Probability Sample
Study Population
Chinese
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

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): NCT04075695


Contacts
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Contact: CZ Chen, PHD +86 13072765173 whuchenchzh@163.com
Contact: XL Wang +86 13117192316 wangxl0807@163.com

Locations
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China, Hubei
Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430000
Contact: CZ Chen, PHD    +86 13072765173    whuchenchzh@163.com   
Contact: XL Wang    +86 13117192316    wangxl0807@163.com   
Sponsors and Collaborators
Renmin Hospital of Wuhan University
Investigators
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Principal Investigator: Renmin Hospital of Wuhan University Renmin Hospital of Wuhan University
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Responsible Party: Changzheng Chen, Chief of Department of Ophthalmology, Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier: NCT04075695    
Other Study ID Numbers: UWFARVO
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

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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
Keywords provided by Changzheng Chen, Renmin Hospital of Wuhan University:
ischemic index
Ultra-wide field fundus fluorescein angiography
vascular leakage index
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases