Retinal Vein OcclusionUWFARVONCT04075695
Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
An observational study of Retinal Vein Occlusion, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2019to 12 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- Male or female aged 18 years or more
- Patients with a diagnosis of CRVO,BRVO or HRVO without macular edema
- Duration of RVO not more than 4 months
- 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
- Patient who agrees to participate to the study and who has given his/her written, informed consent
Who cannot join
- 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
- Active or suspected ocular or periocular infection
- Active severe intraocular inflammation
- RVO complicated with neovascularization
- Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye
- Patient already included in the study for the treatment of the fellow eye
Show all 9Show fewer
- Pregnant or breastfeeding woman
- Lack of effective contraception for women of childbearing age
- Patient taking part in an interventional study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430000
CZ Chen, PHD, +86 13072765173, whuchenchzh@163.com
XL Wang, +86 13117192316, wangxl0807@163.com
About this study
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)
Read the 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.
- Conditions
- Retinal Vein Occlusion
- Keywords
- ischemic index, Ultra-wide field fundus fluorescein angiography, vascular leakage index
- Medical subject headings
- Retinal Vein Occlusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in non-perfused areas in different retinal area
Change in non-perfused areas in different retinal area from Baseline to 1，2，3，6，9and 12 months
Measured: Baseline and1，2，3，6，9and 12 months
Secondary outcomes (2)
Change in best corrected visual acuity
Change in best corrected visual acuity from Baseline to 1，2，3，6，9and 12 months
Measured: Baseline and1，2， 3, 6, 9 and 12 months
Change in central macular thickness
Change in central macular thickness from Baseline to 1，2，3，6，9and 12 months
Measured: Baseline and1，2， 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start18 Sep 2019
- Primary completion12 Dec 2024 (estimated)
- Study completion12 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changzheng Chen, Renmin Hospital of Wuhan University
- Investigators
- Renmin Hospital of Wuhan University, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075695
- Sponsor's protocol ID
- UWFARVO
- Acronym
- UWFARVO
- Status last verified
- Oct 2023
- First submitted
- 29 Aug 2019
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT04075695
- Acronym / sponsor ID
- UWFARVO / UWFARVO
- Conditions
- Retinal Vein Occlusion
- Keywords
- ischemic index, Ultra-wide field fundus fluorescein angiography, vascular leakage index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 12 Dec 2024 (estimated)
- Study completion
- 12 Aug 2025 (estimated)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (5 listed)
- Male or female aged 18 years or more
- Patients with a diagnosis of CRVO,BRVO or HRVO without macular edema
- Duration of RVO not more than 4 months
- 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
- Patient who agrees to participate to the study and who has given his/her written, informed consent
Key exclusion criteria (9 listed)
- 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
- Active or suspected ocular or periocular infection
- Active severe intraocular inflammation
- RVO complicated with neovascularization
- Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Change in best corrected visual acuity
Time frame: Baseline and1，2， 3, 6, 9 and 12 months
Change in central macular thickness
Time frame: Baseline and1，2， 3, 6, 9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
Related trials for Retinal Vein Occlusion
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
Retinal Vein Occlusion (RVO)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renmin Hospital of Wuhan University principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Vein Occlusion, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CZ Chen, PHD (+86 13072765173, whuchenchzh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in non-perfused areas in different retinal area (time frame: Baseline and1，2，3，6，9and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.