Severe Nonproliferative Diabetic RetinopathyNCT03863535
PRP vs PRP+IVC for Severe nPDR
A study testing Conbercept and Panretinal coagulation in people with Severe Nonproliferative Diabetic Retinopathy and Diabetic Retinopathy, run by Ruijin Hospital at 1 site in China.
Trial summary
The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Nonproliferative Diabetic Retinopathy, Diabetic Retinopathy, Diabete Mellitus
- What is being tested?
- Conbercept and Panretinal coagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2019to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II diabetic patients, 18 years and older, were included if the participants had:
- severe non-PDR in either eyes with/without diabetic macular edema;
- ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;
- no previous treatment (of any type) in either eye.
Who cannot join
- history of prior laser treatment or vitrectomy in the study eye;
- history of thromboembolic event - including myocardial infarction or cerebral vascular accident;
- major surgery within the prior 6 months or planned within the next 28 days;
- history of glaucoma or ocular hypertension;
- loss of vision as a result of other causes;
- history of systemic corticosteroid therapy within the last 3 months;
Show all 9Show fewer
- severe systemic disease other than diabetes mellitus;
- known coagulation abnormalities or current use of anticoagulative medication other than aspirin
- any condition that could affect followup or documentation (including preretinal or vitreous hemorrhage).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 20025
Xi Shen, PhD, +86 136-2167-7680, carl_shen2005@126.com
About this study
Official title: Panretinal Photocoagulation (PRP) vs PRP Combined With Intravitreous Conbercept (IVC) for Severe Nonproliferative Diabetic Retinopathy (nPDR): A Randomized Clinical Trial
The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients.
Read the detailed description
This was a prospective, randomized, two-armed study to assess the efficacy and safety of intravitreal conbercept injection plus PRP versus PRP in the treatment of nPDR patients with/without diabetic macular edema for a period of 1 year. This was an investigator-initiated study performed by department of ophthalmology, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.
- Being tested
- Conbercept, Panretinal coagulation
- Keywords
- Conbercept, Panretinal photocoagulation, non-proliferative diabetic retinopathy, diabetic macular edema
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConberceptDrug
Participants were randomized (1:1) to receive IVC+PRP or PRP monotherapy. Patients in IVC+PRP group with diabetic macular edema (DME) received 3 monthly IVC injections along with standard PRP within 1 week after the first injection. Those without DME received 1 lVC injection and standard PRP within 1 week after the injection . Re-treatments in both groups were at the investigators'discretion.
Panretinal coagulationProcedure or surgery
The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal conbercept+Panretinal coagulation | Experimental | Not described Receives: Drug: Conbercept; Procedure: Panretinal coagulation |
| Panretinal coagulation | Active comparator | Not described Receives: Procedure: Panretinal coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best-corrected visual acuity (BCVA)
To assess the effects of two therapies on visual acuity
Measured: from baseline to month 12
Secondary outcomes (3)
Change in central subfield thickness
optical coherence tomography (OCT) for the assessment of central macular thickness
Measured: from baseline to month 12
Fundus fluorescein angiography
fluorescein angiography to measure area of fluorescein leakage (FLA)
Measured: from baseline to month 12
Foveal avascular zone
Optical coherence tomography angiography (OCTA) for measurement of FAZ
Measured: from baseline to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start18 Jan 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Nonproliferative 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Responsible party
- Principal investigator, Xi Shen, Ruijin Hospital
- Investigators
- Xi Shen, MD, Study director, Ruijin HospitalQiong Zhang, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863535
- Sponsor's protocol ID
- Ruijin Hospital
- Status last verified
- Mar 2019
- First submitted
- 27 Jan 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panretinal Photocoagulation (PRP) vs PRP Combined With Intravitreous Conbercept (IVC) for Severe Nonproliferative Diabetic Retinopathy (nPDR): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03863535
- Acronym / sponsor ID
- Ruijin Hospital
- Keywords
- Conbercept, Panretinal photocoagulation, non-proliferative diabetic retinopathy, diabetic macular edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 5 Mar 2019 (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.
The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients.
Detailed description
This was a prospective, randomized, two-armed study to assess the efficacy and safety of intravitreal conbercept injection plus PRP versus PRP in the treatment of nPDR patients with/without diabetic macular edema for a period of 1 year. This was an investigator-initiated study performed by department of ophthalmology, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal conbercept+Panretinal coagulation | Experimental | Drug: Conbercept, Procedure: Panretinal coagulation |
| Panretinal coagulation | Active comparator | Procedure: Panretinal coagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- severe non-PDR in either eyes with/without diabetic macular edema;
- ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;
- no previous treatment (of any type) in either eye.
Key exclusion criteria (9 listed)
- history of prior laser treatment or vitrectomy in the study eye;
- history of thromboembolic event - including myocardial infarction or cerebral vascular accident;
- major surgery within the prior 6 months or planned within the next 28 days;
- history of glaucoma or ocular hypertension;
- loss of vision as a result of other causes;
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 |
|---|---|---|
| ConberceptParticipants were randomized (1:1) to receive IVC+PRP or PRP monotherapy. Patients in IVC+PRP group with diabetic macular edema (DME) received 3 monthly IVC injections along with standard PRP within 1 week after the first injection. Those without DME received 1 lVC injection and standard PRP within 1 week after the injection . Re-treatments in both groups were at the investigators'discretion. | Drug | Intravitreal conbercept+Panretinal coagulation |
| Panretinal coagulationThe PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion. | Procedure or surgery | Intravitreal conbercept+Panretinal coagulation, Panretinal coagulation |
Primary outcome
Change in best-corrected visual acuity (BCVA)
Time frame: from baseline to month 12
To assess the effects of two therapies on visual acuity
3 secondary outcomes
Change in central subfield thickness
Time frame: from baseline to month 12
Fundus fluorescein angiography
Time frame: from baseline to month 12
Foveal avascular zone
Time frame: from baseline to month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
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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, MD study director
Ruijin Hospital
Qiong Zhang, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conbercept and Panretinal coagulation in people with Severe Nonproliferative Diabetic Retinopathy and Diabetic Retinopathy, 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 4 inclusion and 9 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 5 Mar 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.
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 Xi Shen, MD (+86-021-64370045, carl_shen2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best-corrected visual acuity (BCVA) (time frame: from baseline to month 12). 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 5 Mar 2019.