Proliferative Diabetic RetinopathyPhase 4NCT02816710
Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy
A Phase 4 study testing Conbercept in people with Proliferative Diabetic Retinopathy and Tractional Retinal Detachment, run by Ruijin Hospital at 1 site in China.
Trial summary
To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Tractional Retinal Detachment
- 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
- 112 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Sep 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subjects of either sex aged ≥ 18 years.
- Diagnosis of diabetes mellitus (type 1 or type 2);
- Active proliferative diabetic retinopathy was clinically evident;
- Study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage with significant fibrous proliferation, tractional retinal detachment in the posterior pole or complicated retinal detachment, which can be detected by B-scan ultrasonography.
- Ability to give informed consent.
Who cannot join
- Coexistent ocular disease that may interfere with visual outcome;
- Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF) pharmacotherapy in either eye;
- A macula-involving retinal detachment for >6 months in the study eye;
- Iris or angle neovascularization and neovascular glaucoma;
- known allergy to any components of conbercept formulation
- severe external ocular infection;
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- pregnancy or current oral contraceptive intake;
- usage of anticoagulant or antiplatelet therapy;
- preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c) >11.0%];
- uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases;
- <6 months of follow-up post initial surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Conbercept Injection Methods in Treatment of Severe Proliferative Diabetic Retinopathy
To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.
Read the detailed description
To assess the clinical effects of preoperative, intraoperative or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in pars plana vitrectomy (PPV) with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods. These patients were randomly assigned to three groups: Group 1 received an IVC injection 3 to 5 days before surgery; Group 2 received an IVC injection at the end of surgery; and Group 3 received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV. Follow-up examinations were performed for at least six months after surgery.
- Being tested
- Conbercept
- Keywords
- Conbercept, Proliferative diabetic retinopathy, Silicone oil tamponade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConberceptDrug
Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.
| Study group | Role | What they receive |
|---|---|---|
| IVC Preoperative group | Experimental | Conbercept injection before vitrectomy Receives: Drug: Conbercept |
| IVC Postoperative group | Experimental | Conbercept injection at the end of vitrectomy Receives: Drug: Conbercept |
| IVC Pre- and Post-operative group | Experimental | First conbercept injection before vitrectomy and second at the end of operation. Receives: Drug: Conbercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected Visual Acuity
Measured: 6 months
Duration of Surgery
To evaluate the influence of these three methods to the final duration of surgery. We carefully estimated the time of the vitrectomy from insertion to extraction of the 23-gauge three-port trocars.
Measured: during the operation time
Intraoperative Bleeding
The grading criteria for intraoperative bleeding: Grade 1, spontaneous cessation of minor bleeding or bleeding that stopped by transient elevation of perfusion pressure; Grade 2, moderate bleeding requiring endodiathermy or broad blood clots formed far away from the bleeding site; Grade 3, thick blood clots exceeding half of the posterior pole or affecting the operation field.
Measured: Time between the insertion and extraction of three 23-gauge vitrectomy ports
Secondary outcomes (7)
Postoperative Preretinal Blood
The grading criteria for postoperative preretinal blood: Grade 1, isolated blood clots within 10 disk area but without covering the posterior pole; Grade 2, broad blood clots exceeding 10 disk area regardless of involvement of the posterior pole; Grade 3, broad blood clots exceeding 10 disk area as well as involving the posterior pole. Maximal extent of preretinal blood within 1 week postoperatively was used for grading the extent of hemorrhage.
Measured: postoperatively, up to 1 week
Reabsorption Time of Blood
To monitor the reabsorption time of preretinal blood.
Measured: follow up period, up to an average of 6 months after the operation
Recurrent Vitreous Hemorrhage
Recurrent vitreous hemorrhage(VH) was referred to any new episode of VH occurring after one week postoperatively, dividing into early stage (≤ 4 weeks) and late stage (> 4 weeks).
Measured: follow up period, up to an average of 6 months after the operation
Frequency of Intraoperative Electrocoagulation
The number of times electrocoagulation, which was used to stop bleeding, was carefully counted.
Measured: during the operation time
Number of Participants With Neovascular Glaucoma (NVG)
Measured: follow up period, up to an average of 6 months after the operation
Recurrent Retinal Detachment
Measured: follow up period, up to an average of 6 months after the operation
Need for Reoperation
due to recurrent retinal detachment or unclear vitreous hemorrhage
Measured: follow up period, up to an average of 6 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Ruijin 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Shen, Ruijin Hospital
- Investigators
- Xi Shen, PhD, Study director, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816710
- Sponsor's protocol ID
- 2016062501
- Status last verified
- Nov 2019
- First submitted
- 25 Jun 2016
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Conbercept Injection Methods in Treatment of Severe Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT02816710
- Acronym / sponsor ID
- 2016062501
- Keywords
- Conbercept, Proliferative diabetic retinopathy, Silicone oil tamponade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 21 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.
Detailed description
To assess the clinical effects of preoperative, intraoperative or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in pars plana vitrectomy (PPV) with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods. These patients were randomly assigned to three groups: Group 1 received an IVC injection 3 to 5 days before surgery; Group 2 received an IVC injection at the end of surgery; and Group 3 received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV. Follow-up examinations were performed for at least six months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IVC Preoperative group | Experimental | Drug: ConberceptConbercept injection before vitrectomy |
| IVC Postoperative group | Experimental | Drug: ConberceptConbercept injection at the end of vitrectomy |
| IVC Pre- and Post-operative group | Experimental | Drug: ConberceptFirst conbercept injection before vitrectomy and second at the end of operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects of either sex aged ≥ 18 years.
- Diagnosis of diabetes mellitus (type 1 or type 2);
- Active proliferative diabetic retinopathy was clinically evident;
- Study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage with significant fibrous proliferation, tractional retinal detachment in the posterior pole or complicated retinal detachment, which can be detected by B-scan ultrasonography.
- Ability to give informed consent.
Key exclusion criteria (11 listed)
- Coexistent ocular disease that may interfere with visual outcome;
- Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF) pharmacotherapy in either eye;
- A macula-involving retinal detachment for >6 months in the study eye;
- Iris or angle neovascularization and neovascular glaucoma;
- known allergy to any components of conbercept formulation
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 |
|---|---|---|
| ConberceptConbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists. | Drug | IVC Postoperative group, IVC Pre- and Post-operative group, IVC Preoperative group |
Primary outcome
Best-corrected Visual Acuity
Time frame: 6 months
Duration of Surgery
Time frame: during the operation time
To evaluate the influence of these three methods to the final duration of surgery. We carefully estimated the time of the vitrectomy from insertion to extraction of the 23-gauge three-port trocars.
Intraoperative Bleeding
Time frame: Time between the insertion and extraction of three 23-gauge vitrectomy ports
The grading criteria for intraoperative bleeding: Grade 1, spontaneous cessation of minor bleeding or bleeding that stopped by transient elevation of perfusion pressure; Grade 2, moderate bleeding requiring endodiathermy or broad blood clots formed far away from the bleeding site; Grade 3, thick blood clots exceeding half of the posterior pole or affecting the operation field.
7 secondary outcomes
Postoperative Preretinal Blood
Time frame: postoperatively, up to 1 week
Reabsorption Time of Blood
Time frame: follow up period, up to an average of 6 months after the operation
Recurrent Vitreous Hemorrhage
Time frame: follow up period, up to an average of 6 months after the operation
Frequency of Intraoperative Electrocoagulation
Time frame: during the operation time
Number of Participants With Neovascular Glaucoma (NVG)
Time frame: follow up period, up to an average of 6 months after the operation
Recurrent Retinal Detachment
Time frame: follow up period, up to an average of 6 months after the operation
Need for Reoperation
Time frame: follow up period, up to an average of 6 months after the operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Xi Shen, PhD study director
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conbercept in people with Proliferative Diabetic Retinopathy and Tractional Retinal Detachment, run by Ruijin 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 5 inclusion and 11 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 21 Nov 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 6 months). The study lists 3 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 21 Nov 2019.