Diabetic Macular EdemaNCT04668703
Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema
A study testing Conbercept intravitreal injection in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Eye & ENT Hospital of Fudan University.
Trial summary
Diabetic macular edema (DME) is an important cause of central vision impairment among people with diabetic retinopathy (DR), which can have a significant adverse effect on daily activities and quality of life. Diabetic patients with preexisting DME are at increased risk of worsening edema following cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Diabetic Retinopathy, Cataract Diabetic
- What is being tested?
- Conbercept intravitreal injection
- 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
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients sign informed consent, and are willing and able to comply with all the follow-ups
- Age ≥ 18 years , both genders
- Diagnosis of type 1 or type 2 diabetes mellitus
- Serum HbA1c ≤ 10%
- Patients with a diagnosis of DR (ETDRS 35-53) and cataract
Who cannot join
- CI-DME
- Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy
- History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases
- Received anti- VEGF treatment (including intravitreal injection or systematic application) within three months prior to enrollment
- History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to enrollment, or possibly need panretinal photocoagulation of the study eye during the study
- Intraocular conventional surgery within the past three months
Show all 21Show fewer
- Traumatic cataract or congenital bilateral cataract in the study eye
- Active ocular or periocular infection in either eye
- Iris neovascularization in the study eye
- Uncontrolled glaucoma, or history of glaucoma surgery
- Aphakia in the study eye
- History of vitrectomy in the study eye
- The density of corneal endothelial cells is lower than 2000/mm2
- Patients with uncontrolled hyperglycemia, or Hemoglobin A1C (HbA1c) ≥10.0%, or under hemodialysis, or started insulin usage within the last 4 months, or expected to start insulin use for hyperglycemia control in the next 4 months
- Any surgical contraindications
- Uncontrolled Blood Pressure
- Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month
- Renal Failure
- Pregnant or breast-feeding women
- Participation in another simultaneous medical investigator or trial
- Other situations where the researcher judges that the patient is not suitable for inclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema in Cataract Patients With Diabetic Retinopathy
Diabetic macular edema (DME) is an important cause of central vision impairment among people with diabetic retinopathy (DR), which can have a significant adverse effect on daily activities and quality of life. Diabetic patients with preexisting DME are at increased risk of worsening edema following cataract surgery. Previous studies also reported progression of DR after cataract surgery. Clinically significant DME is now classified into center-involved DME (CI-DME) and non center-involved DME (non-CI DME). Randomized clinical trials have established intravitreal antivascular endothelial growth factor (VEGF) therapy as first-line treatment for visual impairment from CI-DME and studies have addressed the influence of anti-VEGF therapy among patients with DME undergoing cataract surgery. However, for patients with non-CI DME before cataract surgery, whether anti-VEGF therapy is necessary at the end of surgery to prevent CI-DME is still clinically controversial. In order to evaluate the prophylactic effect of Conbercept (a recombinant fusion protein with high affinity to all VEGF isoforms and PIGF) intravitreal injection at the conclusion of cataract surgery for DME in patients with DR, the investigators will prospectively recruit 40 cataract patients with DR and non-CI DME and randomly assign these subjects into the study group (combined cataract surgery and intravitreal Conbercept injection, 20 cases) and the control group (cataract surgery alone, 20 cases). The primary outcomes include mean changes in central retinal thickness (CRT) and in diabetic retinopathy severity score (DRSS). The secondary outcomes include changes in best corrected visual acuity (BCVA), foveal avascular zone (FAZ), retinal vessel density (VD), the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8.
- Being tested
- Conbercept intravitreal injection
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conbercept intravitreal injectionProcedure or surgery
intravitreal injection of 0.5 mg conbercept at the conclusion of cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| combined cataract surgery and intravitreal Conbercept injection | Experimental | Subjects will receive conbercept injections at a dose of 0.5 mg/eye at the conclusion of cataract surgery. Receives: Procedure: Conbercept intravitreal injection |
| cataract surgery alone | No intervention | Subjects will undergo cataract surgery by phacoemulsification and intraocular lens implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in central retinal thickness (CRT) with optical coherence tomography (OCT)
to compare the mean change from baseline of CRT between treatment group and control group at month 1 and 3
Measured: Baseline, 1 month and 3 month after operation
change in diabetic retinopathy severity score (DRSS)
to compare the mean change from baseline of DRSS between treatment group and control group at month 1 and 3
Measured: Baseline, 1 month and 3 month after operation
Secondary outcomes (4)
change in best corrected visual acuity (BCVA)
Measured: Baseline, 1 month and 3 month after operation
change in foveal avascular zone (FAZ) with optical coherence tomography angiography (OCTA)
Measured: Baseline, 1 month and 3 month after operation
change in retinal vessel density (VD) with optical coherence tomography angiography (OCTA)
Measured: Baseline, 1 month and 3 month after operation
change in the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8
Measured: Baseline, 1 week, 1 month and 3 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin Yang, MD, ph.D., Study chair, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668703
- Sponsor's protocol ID
- Yumeng Shi
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glassman AR, Wells JA 3rd, Josic K, Maguire MG, Antoszyk AN, Baker C, Beaulieu WT, Elman MJ, Jampol LM, Sun JK. Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study). Ophthalmology. 2020 Sep;127(9):1201-1210. doi: 10.1016/j.ophtha.2020.03.021. Epub 2020 Mar 29.
PubMed 32402554Zhang J, Liang Y, Xie J, Li D, Hu Q, Li X, Zheng W, He R. Conbercept for patients with age-related macular degeneration: a systematic review. BMC Ophthalmol. 2018 Jun 15;18(1):142. doi: 10.1186/s12886-018-0807-1.
PubMed 29902977Relhan N, Flynn HW Jr. The Early Treatment Diabetic Retinopathy Study historical review and relevance to today's management of diabetic macular edema. Curr Opin Ophthalmol. 2017 May;28(3):205-212. doi: 10.1097/ICU.0000000000000362.
PubMed 28151747Peterson SR, Silva PA, Murtha TJ, Sun JK. Cataract Surgery in Patients with Diabetes: Management Strategies. Semin Ophthalmol. 2018;33(1):75-82. doi: 10.1080/08820538.2017.1353817. Epub 2017 Nov 16.
PubMed 29144826Grzybowski A, Kanclerz P, Huerva V, Ascaso FJ, Tuuminen R. Diabetes and Phacoemulsification Cataract Surgery: Difficulties, Risks and Potential Complications. J Clin Med. 2019 May 20;8(5):716. doi: 10.3390/jcm8050716.
PubMed 31137510Heier JS, Korobelnik JF, Brown DM, Schmidt-Erfurth U, Do DV, Midena E, Boyer DS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Vitti R, Berliner AJ, Zeitz O, Metzig C, Holz FG. Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology. 2016 Nov;123(11):2376-2385. doi: 10.1016/j.ophtha.2016.07.032. Epub 2016 Sep 17.
PubMed 27651226Ip MS, Zhang J, Ehrlich JS. The Clinical Importance of Changes in Diabetic Retinopathy Severity Score. Ophthalmology. 2017 May;124(5):596-603. doi: 10.1016/j.ophtha.2017.01.003. Epub 2017 Mar 8.
PubMed 28284785Dhoot DS, Baker K, Saroj N, Vitti R, Berliner AJ, Metzig C, Thompson D, Singh RP. Baseline Factors Affecting Changes in Diabetic Retinopathy Severity Scale Score After Intravitreal Aflibercept or Laser for Diabetic Macular Edema: Post Hoc Analyses from VISTA and VIVID. Ophthalmology. 2018 Jan;125(1):51-56. doi: 10.1016/j.ophtha.2017.06.029. Epub 2017 Jul 29.
PubMed 28764888
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema in Cataract Patients With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04668703
- Acronym / sponsor ID
- Yumeng Shi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 16 Dec 2020 (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.
Diabetic macular edema (DME) is an important cause of central vision impairment among people with diabetic retinopathy (DR), which can have a significant adverse effect on daily activities and quality of life. Diabetic patients with preexisting DME are at increased risk of worsening edema following cataract surgery. Previous studies also reported progression of DR after cataract surgery. Clinically significant DME is now classified into center-involved DME (CI-DME) and non center-involved DME (non-CI DME). Randomized clinical trials have established intravitreal antivascular endothelial growth factor (VEGF) therapy as first-line treatment for visual impairment from CI-DME and studies have addressed the influence of anti-VEGF therapy among patients with DME undergoing cataract surgery. However, for patients with non-CI DME before cataract surgery, whether anti-VEGF therapy is necessary at the end of surgery to prevent CI-DME is still clinically controversial. In order to evaluate the prophylactic effect of Conbercept (a recombinant fusion protein with high affinity to all VEGF isoforms and PIGF) intravitreal injection at the conclusion of cataract surgery for DME in patients with DR, the investigators will prospectively recruit 40 cataract patients with DR and non-CI DME and randomly assign these subjects into the study group (combined cataract surgery and intravitreal Conbercept injection, 20 cases) and the control group (cataract surgery alone, 20 cases). The primary outcomes include mean changes in central retinal thickness (CRT) and in diabetic retinopathy severity score (DRSS). The secondary outcomes include changes in best corrected visual acuity (BCVA), foveal avascular zone (FAZ), retinal vessel density (VD), the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined cataract surgery and intravitreal Conbercept injection | Experimental | Procedure: Conbercept intravitreal injectionSubjects will receive conbercept injections at a dose of 0.5 mg/eye at the conclusion of cataract surgery. |
| cataract surgery alone | No intervention | –Subjects will undergo cataract surgery by phacoemulsification and intraocular lens implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients sign informed consent, and are willing and able to comply with all the follow-ups
- Age ≥ 18 years , both genders
- Diagnosis of type 1 or type 2 diabetes mellitus
- Serum HbA1c ≤ 10%
- Patients with a diagnosis of DR (ETDRS 35-53) and cataract
Key exclusion criteria (21 listed)
- CI-DME
- Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy
- History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases
- Received anti- VEGF treatment (including intravitreal injection or systematic application) within three months prior to enrollment
- History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to enrollment, or possibly need panretinal photocoagulation of the study eye during the study
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 |
|---|---|---|
| Conbercept intravitreal injectionintravitreal injection of 0.5 mg conbercept at the conclusion of cataract surgery | Procedure or surgery | combined cataract surgery and intravitreal Conbercept injection |
Primary outcome
change in central retinal thickness (CRT) with optical coherence tomography (OCT)
Time frame: Baseline, 1 month and 3 month after operation
to compare the mean change from baseline of CRT between treatment group and control group at month 1 and 3
change in diabetic retinopathy severity score (DRSS)
Time frame: Baseline, 1 month and 3 month after operation
to compare the mean change from baseline of DRSS between treatment group and control group at month 1 and 3
4 secondary outcomes
change in best corrected visual acuity (BCVA)
Time frame: Baseline, 1 month and 3 month after operation
change in foveal avascular zone (FAZ) with optical coherence tomography angiography (OCTA)
Time frame: Baseline, 1 month and 3 month after operation
change in retinal vessel density (VD) with optical coherence tomography angiography (OCTA)
Time frame: Baseline, 1 month and 3 month after operation
change in the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8
Time frame: Baseline, 1 week, 1 month and 3 month after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Background: PubMed 32402554Glassman AR, Wells JA 3rd, Josic K, Maguire MG, Antoszyk AN, Baker C, Beaulieu WT, Elman MJ, Jampol LM, Sun JK. Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study). Ophthalmology. 2020 Sep;127(9):1201-1210. doi: 10.1016/j.ophtha.2020.03.021. Epub 2020 Mar 29.
- Background: PubMed 29902977Zhang J, Liang Y, Xie J, Li D, Hu Q, Li X, Zheng W, He R. Conbercept for patients with age-related macular degeneration: a systematic review. BMC Ophthalmol. 2018 Jun 15;18(1):142. doi: 10.1186/s12886-018-0807-1.
- Background: PubMed 28151747Relhan N, Flynn HW Jr. The Early Treatment Diabetic Retinopathy Study historical review and relevance to today's management of diabetic macular edema. Curr Opin Ophthalmol. 2017 May;28(3):205-212. doi: 10.1097/ICU.0000000000000362.
- Background: PubMed 29144826Peterson SR, Silva PA, Murtha TJ, Sun JK. Cataract Surgery in Patients with Diabetes: Management Strategies. Semin Ophthalmol. 2018;33(1):75-82. doi: 10.1080/08820538.2017.1353817. Epub 2017 Nov 16.
- Background: PubMed 31137510Grzybowski A, Kanclerz P, Huerva V, Ascaso FJ, Tuuminen R. Diabetes and Phacoemulsification Cataract Surgery: Difficulties, Risks and Potential Complications. J Clin Med. 2019 May 20;8(5):716. doi: 10.3390/jcm8050716.
- Background: PubMed 27651226Heier JS, Korobelnik JF, Brown DM, Schmidt-Erfurth U, Do DV, Midena E, Boyer DS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Vitti R, Berliner AJ, Zeitz O, Metzig C, Holz FG. Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology. 2016 Nov;123(11):2376-2385. doi: 10.1016/j.ophtha.2016.07.032. Epub 2016 Sep 17.
- Background: PubMed 28284785Ip MS, Zhang J, Ehrlich JS. The Clinical Importance of Changes in Diabetic Retinopathy Severity Score. Ophthalmology. 2017 May;124(5):596-603. doi: 10.1016/j.ophtha.2017.01.003. Epub 2017 Mar 8.
- Background: PubMed 28764888Dhoot DS, Baker K, Saroj N, Vitti R, Berliner AJ, Metzig C, Thompson D, Singh RP. Baseline Factors Affecting Changes in Diabetic Retinopathy Severity Scale Score After Intravitreal Aflibercept or Laser for Diabetic Macular Edema: Post Hoc Analyses from VISTA and VIVID. Ophthalmology. 2018 Jan;125(1):51-56. doi: 10.1016/j.ophtha.2017.06.029. Epub 2017 Jul 29.
- 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.
Jin Yang, MD, ph.D. study chair
Eye & ENT Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing Conbercept intravitreal injection in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Eye & ENT Hospital of Fudan 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 5 inclusion and 21 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 16 Dec 2020. 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 Jin Yang, MD, ph.D. (+8613671632525, jin_er76@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in central retinal thickness (CRT) with optical coherence tomography (OCT) (time frame: Baseline, 1 month and 3 month after operation). The study lists 2 primary outcomes in all. 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 NCT04668703, which also lists 8 linked publications.
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 16 Dec 2020.