Retinal Vein OcclusionUWFA-RVO-MENCT04140448
Ultra-wide-field Fluorescein Angiography in Patients With Macular Edema Secondary to Retinal Vein Occlusion
An observational study of Retinal Vein Occlusion and Macular Edema, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
This study mainly observed the ischemic index and vascular leakage index changes on ultra-wide field fluorescence angiography after anti-VEGF treatment , and whether these changes correlated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Macular Edema
- What is being tested?
- Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] and Ultra-wide Fluorescein Angiography
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2023to 15 Dec 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 older
- Macular edema secondary to CRVO,BRVO or HRVO
- Duration of RVO not more than 4 months
- Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) completely resolved (normalization of visual acuity and fundus examination) and who have experienced a recurrence of RVO are also considered naive
- Patient who agrees to participate in 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, 430060
CZ Chen, PHD, +86 13072765173, whuchenchzh@163.com
XL Wang, +86 13117192316, wangxl0807@163.com
About this study
This study mainly observed the ischemic index and vascular leakage index changes on ultra-wide field fluorescence angiography after anti-VEGF treatment , and whether these changes correlated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion.
Read the detailed description
Ultra-wide field fluorescence angiography can clearly observe the peripheral retina. This study mainly observes the ischemic index and vascular leakage index changes on UWFA after anti-VEGF treatment and evaluates these changes associated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion.
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Being tested
- Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS], Ultra-wide Fluorescein Angiography
- Keywords
- Ultra-wide field fundus fluorescein angiography, ischemic index, leakage index
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]Drug
Also called Lucentis, Anti-VEGF
Intravitreal injection of Ranibizumab 0.5 MG/0.05 ML
Ultra-wide Fluorescein AngiographyDevice
Ultra-wide-field Fluorescein Angiography can clearly observe the peripheral retina
| Study group | Role | What they receive |
|---|---|---|
| UWFA-RVO-ME | Ultra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab Receives: Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]; Device: Ultra-wide Fluorescein Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular leakage index in different retinal area
Change in vascular leakage index in different retinal area from baseline to 1,2,3,4,6,9 and 12 months
Measured: Baseline and 1,2,3,4,6,9 and 12 months
Change in non-perfused areas in different retinal area
Change in non-perfused areas in different retinal area from baseline to 1,2,3,4,6,9 and 12 months
Measured: Baseline and 1,2,3,4,6,9 and 12 months
Secondary outcomes (2)
Change in best corrected visual acuity
Change in best corrected visual acuity from baseline to 1,2,3,4,6,9 and 12 months
Measured: Baseline and 1,2,3,4,6,9 and 12 months
Change in central macular thickness
Change in central macular thickness from baseline to1,2,3,4,6,9 and12 months
Measured: Baseline and 1,2,3,4,6,9 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 posted25 Oct 2019
- Study start9 Oct 2023 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion15 Dec 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
- CZ Chen, PHD, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140448
- Sponsor's protocol ID
- UWFA-RVO-ME
- Acronym
- UWFA-RVO-ME
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 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 Macular Edema Secondary to Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT04140448
- Acronym / sponsor ID
- UWFA-RVO-ME / UWFA-RVO-ME
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Keywords
- Ultra-wide field fundus fluorescein angiography, ischemic index, 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
- 9 Oct 2023 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 25 Oct 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.
This study mainly observed the ischemic index and vascular leakage index changes on ultra-wide field fluorescence angiography after anti-VEGF treatment , and whether these changes correlated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion.
Detailed description
Ultra-wide field fluorescence angiography can clearly observe the peripheral retina. This study mainly observes the ischemic index and vascular leakage index changes on UWFA after anti-VEGF treatment and evaluates these changes associated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UWFA-RVO-ME | – | Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS], Device: Ultra-wide Fluorescein AngiographyUltra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab |
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 older
- Macular edema secondary to CRVO,BRVO or HRVO
- Duration of RVO not more than 4 months
- Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) completely resolved (normalization of visual acuity and fundus examination) and who have experienced a recurrence of RVO are also considered naive
- Patient who agrees to participate in 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]Also: Lucentis, Anti-VEGFIntravitreal injection of Ranibizumab 0.5 MG/0.05 ML | Drug | UWFA-RVO-ME |
| Ultra-wide Fluorescein AngiographyUltra-wide-field Fluorescein Angiography can clearly observe the peripheral retina | Device | UWFA-RVO-ME |
Primary outcome
Change in vascular leakage index in different retinal area
Time frame: Baseline and 1,2,3,4,6,9 and 12 months
Change in vascular leakage index in different retinal area from baseline to 1,2,3,4,6,9 and 12 months
Change in non-perfused areas in different retinal area
Time frame: Baseline and 1,2,3,4,6,9 and 12 months
Change in non-perfused areas in different retinal area from baseline to 1,2,3,4,6,9 and 12 months
2 secondary outcomes
Change in best corrected visual acuity
Time frame: Baseline and 1,2,3,4,6,9 and 12 months
Change in central macular thickness
Time frame: Baseline and 1,2,3,4,6,9 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.
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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.
CZ Chen, PHD 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 and Macular Edema, 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 vascular leakage index in different retinal area (time frame: Baseline and 1,2,3,4,6,9 and 12 months). The study lists 2 primary outcomes in all. 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.