Anti-VEGFNCT03633266
Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
A study testing anti-VEGF and PRP in people with Anti-VEGF and Proliferative Diabetic Retinopathy, run by Wenzhou Medical University.
Trial summary
To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anti-VEGF, Proliferative Diabetic Retinopathy, PRP
- What is being tested?
- anti-VEGF and PRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Dec 2022
- 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;
- type 1 or type 2 diabetes.
- proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;
- The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus
Who cannot join
- Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;
- Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;
- anterior chamber neovascularization or neovascular glaucoma;
- other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;
- received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility Study of Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.
- Conditions
- Anti-VEGF, Proliferative Diabetic Retinopathy, PRP, Vitrectomy
- Being tested
- anti-VEGF, PRP
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
PRPProcedure or surgery
vitreoretinal surgery combined with intraoperative PRP
| Study group | Role | What they receive |
|---|---|---|
| anti-VEGF | Experimental | experimental group: vitreoretinal surgery combined with intraoperative anti-VEGF Receives: Procedure: anti-VEGF |
| PRP | Active comparator | Control group: vitreoretinal surgery combined with intraoperative PRP Receives: Procedure: PRP |
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 sructure 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 posted16 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2022 (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
- 220 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
- NCT03633266
- Sponsor's protocol ID
- 10007
- Status last verified
- Aug 2018
- First submitted
- 2 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 PRP in Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03633266
- Acronym / sponsor ID
- 10007
- Conditions
- Anti-VEGF, Proliferative Diabetic Retinopathy, PRP, Vitrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 16 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 vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.
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-VEGFexperimental group: vitreoretinal surgery combined with intraoperative anti-VEGF |
| PRP | Active comparator | Procedure: PRPControl group: vitreoretinal surgery combined with intraoperative PRP |
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;
- type 1 or type 2 diabetes.
- proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;
- The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus
Key exclusion criteria (5 listed)
- Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;
- Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;
- anterior chamber neovascularization or neovascular glaucoma;
- other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;
- received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.
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 |
| PRPvitreoretinal surgery combined with intraoperative PRP | Procedure or surgery | PRP |
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 sructure 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 PRP in people with Anti-VEGF and Proliferative Diabetic Retinopathy, 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 5 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.