Early Proliferative Diabetic RetinopathyEarly Phase 1NCT03426540
Intravitreal Conbercept After Vitrectomy
A Early Phase 1 study testing Conbercept in people with Early Proliferative Diabetic Retinopathy, run by Tianjin Medical University Eye Hospital.
Trial summary
To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR). Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. Read more about this study
- Who is it for?
- Ages 28 to 80 years
- Conditions the study is for
- Early Proliferative Diabetic Retinopathy
- What is being tested?
- Conbercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 28 Feb 2019
- Phase
- Early Phase 1
- 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 28 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We enrolled 50 eyes from 50 patients that were affected by VH as a consequence of early active PDR.
- Patients with non-clearing VH and fibrocellular proliferation without TRD who underwent PPV at Tianjin Medical University Eye Hospital were included in the study.
Who cannot join
- A history of previous PPV;
- Severe intraoperative complications
- Postoperative silicone oil tamponade;
- Menstruation;
- Stroke, a thromboembolic event, or myocardial infarction in the previous
- months contraindicating the withdrawal of anti-platelet and anti-coagulant medications.
About this study
Official title: Safety and Efficacy of Intravitreal Conbercept Injection After Vitrectomy for the Treatment of Early Proliferative Diabetic Retinopathy
To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR).
Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual outcomes of surgery for early-stage PDR.
Read the detailed description
The drug conbercept (an anti-vascular endothelial growth factors) was recently made available for management of early prolific diabetic retinopathy, but its safety and efficacy still require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early proliferative diabetic retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment group and control after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not.
At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure and central retinal thickness will be measured and fundoscopy be performed.
The patients are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, physical examinations and postoperative complications
- Conditions
- Early Proliferative Diabetic Retinopathy
- Being tested
- Conbercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConberceptDrug
Three-port 25-G PPV was performed in all patients using a Constellation system. Patients in the treatment group received an intravitreal injection of conbercept (10 mg/mL, 0.5 mg) using a sterile technique after 25-G vitrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Conbercept | Experimental | intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery Receives: Drug: Conbercept |
| control group | No intervention | Pars plana vitrectomy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
BCVA using a Landolt C acuity chart method
Measured: baseline to 24 weeks post-surgery
Secondary outcomes (2)
postoperative complications
postoperative complications
Measured: baseline to 24 weeks post-surgery
central retinal thickness
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, one-dimensional images
Measured: baseline to 24 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Jan 2017
- Primary completion30 Mar 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Proliferative Diabetic RetinopathyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenchuan Zheng, Tianjin Medical University Eye Hospital
- Investigators
- Rong X Li, MD,PhD, Principal investigator, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426540
- Sponsor's protocol ID
- 2016KY-09
- Status last verified
- Apr 2019
- First submitted
- 26 Jan 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wazan LE, Widhibrata A, Liu GS. Soluble FLT-1 in angiogenesis: pathophysiological roles and therapeutic implications. Angiogenesis. 2024 Nov;27(4):641-661. doi: 10.1007/s10456-024-09942-8. Epub 2024 Aug 29.
PubMed 39207600
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intravitreal Conbercept Injection After Vitrectomy for the Treatment of Early Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03426540
- Acronym / sponsor ID
- 2016KY-09
- Conditions
- Early Proliferative Diabetic Retinopathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 8 Feb 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 safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR).
Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual outcomes of surgery for early-stage PDR.
Detailed description
The drug conbercept (an anti-vascular endothelial growth factors) was recently made available for management of early prolific diabetic retinopathy, but its safety and efficacy still require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early proliferative diabetic retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment group and control after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not.
At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure and central retinal thickness will be measured and fundoscopy be performed.
The patients are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, physical examinations and postoperative complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conbercept | Experimental | Drug: Conberceptintravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery |
| control group | No intervention | –Pars plana vitrectomy alone |
Who may qualify
- Ages
- 28 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- We enrolled 50 eyes from 50 patients that were affected by VH as a consequence of early active PDR.
- Patients with non-clearing VH and fibrocellular proliferation without TRD who underwent PPV at Tianjin Medical University Eye Hospital were included in the study.
Key exclusion criteria (6 listed)
- A history of previous PPV;
- Severe intraoperative complications
- Postoperative silicone oil tamponade;
- Menstruation;
- Stroke, a thromboembolic event, or myocardial infarction in the previous
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 |
|---|---|---|
| ConberceptThree-port 25-G PPV was performed in all patients using a Constellation system. Patients in the treatment group received an intravitreal injection of conbercept (10 mg/mL, 0.5 mg) using a sterile technique after 25-G vitrectomy. | Drug | Conbercept |
Primary outcome
best corrected visual acuity
Time frame: baseline to 24 weeks post-surgery
BCVA using a Landolt C acuity chart method
2 secondary outcomes
postoperative complications
Time frame: baseline to 24 weeks post-surgery
central retinal thickness
Time frame: baseline to 24 weeks post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Derived from this study: PubMed 39207600Wazan LE, Widhibrata A, Liu GS. Soluble FLT-1 in angiogenesis: pathophysiological roles and therapeutic implications. Angiogenesis. 2024 Nov;27(4):641-661. doi: 10.1007/s10456-024-09942-8. Epub 2024 Aug 29.
- Individual participant dataSharing planned: No
Related trials for Early Proliferative Diabetic Retinopathy
Recruiting
Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy (PDR)
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.
Rong X Li, MD,PhD principal investigator
Tianjin Medical University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Conbercept in people with Early Proliferative Diabetic Retinopathy, run by Tianjin Medical University Eye Hospital.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 30 Apr 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best corrected visual acuity (time frame: baseline to 24 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03426540, which also lists 1 linked publication.
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 30 Apr 2019.