Anti-VEGFNCT03637283
Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
A study testing anti-VEGF and fan-shaped photocoagulation in people with Anti-VEGF and Branch Retinal Vein Occlusion, run by Wenzhou Medical University.
Trial summary
To evaluate the efficacy and safety of Anti-VEGF instead of intraoperative fan-shaped photocoagulation in BRVO combined with vitreous hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anti-VEGF, Branch Retinal Vein Occlusion, Vitrectomy
- What is being tested?
- anti-VEGF and fan-shaped photocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Dec 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- BRVO is diagnosed
- Vitreous hemorrhage
- Vitreous hemorrhage combined with mild retinal fibrovascular proliferation (early fibrous vascular membrane, thin fibrous vascular membrane, loose retinal adhesion and intact local retinal structure)
Who cannot join
- BRVO combined with severe retinal fibrovascular proliferation (long-term fibrovascular membrane, thick fibrous vascular membrane and tightly attached to the retina, deformation of local retinal, retinal tear or suspension of retinal vein )
- BRVO combined with retinal detachment
- Retinal veins are completely whitened
- iris neovascularization or neovascular glaucoma
- Combined glaucoma
- combined with other retinopathy
- Received anti-VEGF treatment within 3 months before surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility Study of Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
To evaluate the efficacy and safety of Anti-VEGF instead of intraoperative fan-shaped photocoagulation in BRVO combined with vitreous hemorrhage.
- Conditions
- Anti-VEGF, Branch Retinal Vein Occlusion, Vitrectomy
- Being tested
- anti-VEGF, fan-shaped photocoagulation
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-VEGFProcedure or surgery
vitreoretinal surgery combined with intraoperative anti-VEGF
fan-shaped photocoagulationProcedure or surgery
vitreoretinal surgery combined with intraoperative fan-shaped photocoagulation
| Study group | Role | What they receive |
|---|---|---|
| anti-VEGF | Experimental | vitreoretinal surgery combined with intraoperative anti-VEGF Receives: Procedure: anti-VEGF |
| fan-shaped photocoagulation | Active comparator | vitreoretinal surgery combined with fan-shaped photocoagulation Receives: Procedure: fan-shaped photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in best-corrected visual acuity (BCVA)
Assessed using the ETDRS protocol
Measured: 3 years
Secondary outcomes (3)
Mean change from baseline in visual field
Assessed on Humphery(30-2 and 60-4)
Measured: 3 years
chang from baseline in structure of retina
Assessed on Optical Coherence Tomography(OCT)
Measured: 3 years
chang from baseline in retinal neovascularization
Assessed on Fundus Fluorescein Angiography(FFA)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-VEGFStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangtian Zhou, Wenzhou Medical University
- Investigators
- Yong Wei, M.D, Principal investigator, The Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637283
- Sponsor's protocol ID
- 10008
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 17 Aug 2018
- 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 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
- ClinicalTrials.gov ID
- NCT03637283
- Acronym / sponsor ID
- 10008
- Conditions
- Anti-VEGF, Branch Retinal Vein Occlusion, Vitrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 17 Aug 2018 (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.
To evaluate the efficacy and safety of Anti-VEGF instead of intraoperative fan-shaped photocoagulation in BRVO combined with vitreous hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-VEGF | Experimental | Procedure: anti-VEGFvitreoretinal surgery combined with intraoperative anti-VEGF |
| fan-shaped photocoagulation | Active comparator | Procedure: fan-shaped photocoagulationvitreoretinal surgery combined with fan-shaped photocoagulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old;
- BRVO is diagnosed
- Vitreous hemorrhage
- Vitreous hemorrhage combined with mild retinal fibrovascular proliferation (early fibrous vascular membrane, thin fibrous vascular membrane, loose retinal adhesion and intact local retinal structure)
Key exclusion criteria (7 listed)
- BRVO combined with severe retinal fibrovascular proliferation (long-term fibrovascular membrane, thick fibrous vascular membrane and tightly attached to the retina, deformation of local retinal, retinal tear or suspension of retinal vein )
- BRVO combined with retinal detachment
- Retinal veins are completely whitened
- iris neovascularization or neovascular glaucoma
- Combined glaucoma
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 |
|---|---|---|
| anti-VEGFvitreoretinal surgery combined with intraoperative anti-VEGF | Procedure or surgery | anti-VEGF |
| fan-shaped photocoagulationvitreoretinal surgery combined with intraoperative fan-shaped photocoagulation | Procedure or surgery | fan-shaped photocoagulation |
Primary outcome
Mean change from baseline in best-corrected visual acuity (BCVA)
Time frame: 3 years
Assessed using the ETDRS protocol
3 secondary outcomes
Mean change from baseline in visual field
Time frame: 3 years
chang from baseline in structure of retina
Time frame: 3 years
chang from baseline in retinal neovascularization
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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.
Yong Wei, M.D principal investigator
The Eye Hospital of Wenzhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing anti-VEGF and fan-shaped photocoagulation in people with Anti-VEGF and Branch Retinal Vein Occlusion, run by Wenzhou Medical University.
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 4 inclusion and 7 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Yong Wei, M.D (+86 15057551266, weiyongdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in best-corrected visual acuity (BCVA) (time frame: 3 years). 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 17 Aug 2018.