Proliferative Diabetic RetinopathyPhase 2NCT05642793
Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
A Phase 2 study testing proactive Anti-VEGF (conbercept) use and passive Anti-VEGF (conbercept) use in people with Proliferative Diabetic Retinopathy, run by Peking University Third Hospital at 1 site in China.
Trial summary
This is an unmasking randomized clinical trial. the main purpose of this study is to analyze whether posvitrectomy proactive use of conbercept can reduce the rate of postoperative complication in PDR patients. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- proactive Anti-VEGF (conbercept) use and passive Anti-VEGF (conbercept) use
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Mar 2024
- Phase
- Phase 2
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PDR patients undergoing vitrectomy
Who cannot join
- patients who had received intravitreal injection or systemic use of all types of anti-VEGF agents in the recent three months before vitrectomy
- patients who had received intravitreal injection or systemic use of all types of steroid in the recent one month before vitrectomy
- patients who had received complete PRP before vitrectomy
- patients who are pregnant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Huijin Chen, Dr., 86-010-82266359
About this study
This is an unmasking randomized clinical trial. the main purpose of this study is to analyze whether posvitrectomy proactive use of conbercept can reduce the rate of postoperative complication in PDR patients.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- proactive Anti-VEGF (conbercept) use, passive Anti-VEGF (conbercept) use
- Keywords
- vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proactive Anti-VEGF (conbercept) useDrug
preventive intravitreal injection of conbercept 2 weeks after vitrectomy, and repeat at 5 weeks and 8 weeks if either of the following is present: intravitreal VEGF concentration at 2 weeks postop is higher than 100 pg/ml, or clinical presentation of DME, VH or NVG.
passive Anti-VEGF (conbercept) useDrug
No intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG
| Study group | Role | What they receive |
|---|---|---|
| group 1 (proactive use of conbercept after vitrectomy) | Experimental | proactive use of conbercept after vitrectomy Receives: Drug: proactive Anti-VEGF (conbercept) use |
| group 2 (passive use of conbercept after vitrectomy) | Experimental | passive use of conbercept after vitrectomy Receives: Drug: passive Anti-VEGF (conbercept) use |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of postvitrectomy complication
postvitrectomy DME, VH (recurrent or nonabsorbent), NVG
Measured: 6 months
Secondary outcomes (1)
postvitrectomy BCVA
BCVA at 1,3,6 month after vitrectomy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Apr 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Huijin, Peking University Third Hospital
- Investigators
- Huijin Chen, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642793
- Sponsor's protocol ID
- PDR vitrectomy1
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
- ClinicalTrials.gov ID
- NCT05642793
- Acronym / sponsor ID
- PDR vitrectomy1
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- vitrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 8 Dec 2022 (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 is an unmasking randomized clinical trial. the main purpose of this study is to analyze whether posvitrectomy proactive use of conbercept can reduce the rate of postoperative complication in PDR patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 (proactive use of conbercept after vitrectomy) | Experimental | Drug: proactive Anti-VEGF (conbercept) useproactive use of conbercept after vitrectomy |
| group 2 (passive use of conbercept after vitrectomy) | Experimental | Drug: passive Anti-VEGF (conbercept) usepassive use of conbercept after vitrectomy |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PDR patients undergoing vitrectomy
Key exclusion criteria (4 listed)
- patients who had received intravitreal injection or systemic use of all types of anti-VEGF agents in the recent three months before vitrectomy
- patients who had received intravitreal injection or systemic use of all types of steroid in the recent one month before vitrectomy
- patients who had received complete PRP before vitrectomy
- patients who are pregnant
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 |
|---|---|---|
| proactive Anti-VEGF (conbercept) usepreventive intravitreal injection of conbercept 2 weeks after vitrectomy, and repeat at 5 weeks and 8 weeks if either of the following is present: intravitreal VEGF concentration at 2 weeks postop is higher than 100 pg/ml, or clinical presentation of DME, VH or NVG. | Drug | group 1 (proactive use of conbercept after vitrectomy) |
| passive Anti-VEGF (conbercept) useNo intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG | Drug | group 2 (passive use of conbercept after vitrectomy) |
Primary outcome
rate of postvitrectomy complication
Time frame: 6 months
postvitrectomy DME, VH (recurrent or nonabsorbent), NVG
1 secondary outcome
postvitrectomy BCVA
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
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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.
Huijin Chen, Dr. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing proactive Anti-VEGF (conbercept) use and passive Anti-VEGF (conbercept) use in people with Proliferative Diabetic Retinopathy, run by Peking University Third Hospital 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 1 inclusion and 4 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 14 Dec 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Huijin Chen, Dr. (86-010-82266359, chjdoc@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of postvitrectomy complication (time frame: 6 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 14 Dec 2022.