Proliferative Diabetic RetinopathyNCT07144865
Biological Changes in Fibrovascular Membranes of Patients With Proliferative Diabetic Retinopathy Following Faricimab Injection
A study testing conbercept ophthalmic injection （0.5mg） and Faricimab in people with Proliferative Diabetic Retinopathy, run by Bojie Hu at 1 site in China.
Trial summary
DR is a common microvascular complication of DM that significantly impacts vision. Approximately one-third of DM patients develop DR, with 10% progressing to PDR. PDR is characterized by retinal ischemia-induced VEGF overexpression and pathological NV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- conbercept ophthalmic injection （0.5mg） and Faricimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Apr 2025
- 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
- Diagnosis of proliferative diabetic retinopathy; (2) no prior anti-VEGF treatment within three months; (3) presence of fibrovascular membrane; (4) without ocular or systemic comorbidities
Who cannot join
- history of prior vitrectomy; (2) presence of non-proliferative diabetic retinopathy; (3) coexisting systemic or ocular comorbidities, including, but not limited to, glaucoma, retinal vein occlusion, or rhegmatogenous retinal detachment; and (4) received anti-VEGF therapy within 3 months preceding enrolment.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin medical university eye hosipital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: Effects of Anti-VEGF Agents on Angiogenic Factors in FVMs Impact of Anti-VEGF Therapy on Myofibroblast Products and Profibrotic Factors in FVMs Influence of Anti-VEGF Treatment on Pericyte Markers in FVMs
DR is a common microvascular complication of DM that significantly impacts vision. Approximately one-third of DM patients develop DR, with 10% progressing to PDR. PDR is characterized by retinal ischemia-induced VEGF overexpression and pathological NV. NV proliferates along the vitreoretinal interface, potentially forming FVMs that increase RD risk and may lead to TRD.
FVM formation directly affects PPV complexity. Preoperative anti-VEGF injection reduces intraoperative bleeding and eliminates NV, but may accelerate fibrosis. Previous studies mainly focused on angiogenic/profibrotic factor changes in AH/VH, but whether FVM changes mirror these remains unclear.
This study compared mRNA levels of relevant factors in FVMs from PDR patients treated with faricimab versus conbercept, and investigated their effects on angiogenesis and fibrosis progression in FVMs.
Read the detailed description
Diabetic retinopathy (DR) is one of the most common microvascular complications of diabetes that significantly affects the visual health of patients. The incidence of DR is increasing annually worldwide, with approximately one-third of patients with diabetes developing DR and approximately 10% progressing to proliferative diabetic retinopathy (PDR), which is an advanced stage of DR characterised primarily by retinal ischaemia that leads to the overexpression of vascular endothelial growth factor (VEGF) and the formation of abnormal neovascularization. These new blood vessels proliferate along the vitreoretinal interface, potentially resulting in the formation of fibrovascular membranes (FVM). The presence of FVM not only increases the risk of retinal detachment but may also lead to severe complications such as tractional retinal detachment (TRD).
The formation and characteristics of FVMs directly influence the complexity of pars plana vitrectomy (PPV). Preoperative injection of anti-vascular endothelial growth factor (anti-VEGF) agents is an effective strategy to reduce intraoperative bleeding and eliminate neovascularization (NV). However, per previous studies, anti-VEGF therapy may accelerate the progression of fibrosis. Changes in profibrotic factors in FVM have garnered significant interest. Previous studies have mainly focused on the changes in angiogenic and profibrotic factors in the aqueous humor or vitreous humor. However, whether the changes in these factors in the FVM are consistent with those in the vitreous and aqueous humors remains a question worth exploring.
In this study, researchers compared the mRNA levels of relevant factors in the FVMs of patients with PDR treated with faricimab or conbercept. Additionally, we investigated the effects of different anti-VEGF agents on the progression of angiogenesis and fibrosis in the FVMs of patients with PDR.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- conbercept ophthalmic injection （0.5mg）, Faricimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conbercept ophthalmic injection （0.5mg）Drug
Also called conbercept
Participants were randomly assigned to receive intravitreal injections of either faricimab (IVF, n=4) or conbercept (IVC, n=4) based on a randomisation protocol. To establish a baseline comparison, FVMs were obtained from three treatment-naive patients who served as controls. All participants underwent surgery 4 days after the intravitreal anti-VEGF injections.
FaricimabDrug
According to the randomization protocol, participants were randomly assigned to receive intravitreal injections of faricimab (IVF, n=4) or conbercept (IVC, n=4). To establish a baseline comparison, FVMs were obtained from three treatment-naïve patients as controls. All participants underwent surgery 4 days after intravitreal anti-VEGF injection.
| Study group | Role | What they receive |
|---|---|---|
| Faricimab (IVF) | Active comparator | Participants were randomly assigned to receive intravitreal injections of either faricimab (IVF, n=4) or conbercept (IVC, n=4) based on a randomisation protocol. To establish a baseline comparison, FVMs were obtained from three treatment-naive patients who served as controls. All participants underwent surgery 4 days after the intravitreal anti-VEGF injections. Receives: Drug: Faricimab |
| Conbercept (IVC) | Active comparator | Participants were randomly assigned to receive intravitreal injections of either faricimab (IVF, n=4) or conbercept (IVC, n=4) based on a randomisation protocol. To establish a baseline comparison, FVMs were obtained from three treatment-naive patients who served as controls. All participants underwent surgery 4 days after the intravitreal anti-VEGF injections. Receives: Drug: conbercept ophthalmic injection （0.5mg） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Anti-VEGF Agents on Angiogenic Factors in FVMs
VEGF ANG-2
Measured: 4 days after injection
Concentration of of Anti-VEGF Therapy on Myofibroblast Products and Profibrotic Factors in FVMs
Fibronectin（FN1), connective tissue growth factor (CTGF), alpha-smooth muscle actin (α-SMA), and transforming growth factor beta (TGF-β)
Measured: Four days after the medication injection
Concentration of anti-VEGF treatment on pericyte markers in FVMs
neural glial antigen 2 (NG2), and platelet derived growth factor receptor beta (PDGFR-β)
Measured: Four days after the medication injection
Secondary outcomes (1)
Rate of Neovascularization on FVMs (SNV/SFVM, %)
The areas of FVMs (SFVM) and neovascularization (SNV) were then calculated. The NV of the FVMs was quantified as the SNV/SFVM ratio (NV area to total FVM area).
Measured: 1, 2, 3, and 4 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Dec 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bojie Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bojie Hu, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144865
- Sponsor's protocol ID
- TianjinMUEHhbj100
- Other IDs
- Not provided, not provided
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not considering it for the time being
Publications
Takahashi N, Abe I, Kira S, Ishii Y. Role of epicardial adipose tissue in human atrial fibrillation. J Arrhythm. 2023 Feb 19;39(2):93-110. doi: 10.1002/joa3.12825. eCollection 2023 Apr.
PubMed 37021018Montero JA, Ruiz-Moreno JM, Correa ME. Intravitreal anti-VEGF drugs as adjuvant therapy in diabetic retinopathy surgery. Curr Diabetes Rev. 2011 May;7(3):176-84. doi: 10.2174/157339911795843104.
PubMed 21438852
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-VEGF Agents on Angiogenic Factors in FVMs Impact of Anti-VEGF Therapy on Myofibroblast Products and Profibrotic Factors in FVMs Influence of Anti-VEGF Treatment on Pericyte Markers in FVMs
- ClinicalTrials.gov ID
- NCT07144865
- Acronym / sponsor ID
- TianjinMUEHhbj100
- Conditions
- Proliferative Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bojie HuUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 28 Aug 2025 (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.
DR is a common microvascular complication of DM that significantly impacts vision. Approximately one-third of DM patients develop DR, with 10% progressing to PDR. PDR is characterized by retinal ischemia-induced VEGF overexpression and pathological NV. NV proliferates along the vitreoretinal interface, potentially forming FVMs that increase RD risk and may lead to TRD.
FVM formation directly affects PPV complexity. Preoperative anti-VEGF injection reduces intraoperative bleeding and eliminates NV, but may accelerate fibrosis. Previous studies mainly focused on angiogenic/profibrotic factor changes in AH/VH, but whether FVM changes mirror these remains unclear.
This study compared mRNA levels of relevant factors in FVMs from PDR patients treated with faricimab versus conbercept, and investigated their effects on angiogenesis and fibrosis progression in FVMs.
Detailed description
Diabetic retinopathy (DR) is one of the most common microvascular complications of diabetes that significantly affects the visual health of patients. The incidence of DR is increasing annually worldwide, with approximately one-third of patients with diabetes developing DR and approximately 10% progressing to proliferative diabetic retinopathy (PDR), which is an advanced stage of DR characterised primarily by retinal ischaemia that leads to the overexpression of vascular endothelial growth factor (VEGF) and the formation of abnormal neovascularization. These new blood vessels proliferate along the vitreoretinal interface, potentially resulting in the formation of fibrovascular membranes (FVM). The presence of FVM not only increases the risk of retinal detachment but may also lead to severe complications such as tractional retinal detachment (TRD).
The formation and characteristics of FVMs directly influence the complexity of pars plana vitrectomy (PPV). Preoperative injection of anti-vascular endothelial growth factor (anti-VEGF) agents is an effective strategy to reduce intraoperative bleeding and eliminate neovascularization (NV). However, per previous studies, anti-VEGF therapy may accelerate the progression of fibrosis. Changes in profibrotic factors in FVM have garnered significant interest. Previous studies have mainly focused on the changes in angiogenic and profibrotic factors in the aqueous humor or vitreous humor. However, whether the changes in these factors in the FVM are consistent with those in the vitreous and aqueous humors remains a question worth exploring.
In this study, researchers compared the mRNA levels of relevant factors in the FVMs of patients with PDR treated with faricimab or conbercept. Additionally, we investigated the effects of different anti-VEGF agents on the progression of angiogenesis and fibrosis in the FVMs of patients with PDR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faricimab (IVF) | Active comparator | Drug: FaricimabParticipants were randomly assigned to receive intravitreal injections of either faricimab (IVF, n=4) or conbercept (IVC, n=4) based on a randomisation protocol. To establish a baseline comparison, FVMs were obtained from three treatment-naive patients who served as controls. All participants underwent surgery 4 days after the intravitreal anti-VEGF injections. |
| Conbercept (IVC) | Active comparator | Drug: conbercept ophthalmic injection （0.5mg）Participants were randomly assigned to receive intravitreal injections of either faricimab (IVF, n=4) or conbercept (IVC, n=4) based on a randomisation protocol. To establish a baseline comparison, FVMs were obtained from three treatment-naive patients who served as controls. All participants underwent surgery 4 days after the intravitreal anti-VEGF injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of proliferative diabetic retinopathy; (2) no prior anti-VEGF treatment within three months; (3) presence of fibrovascular membrane; (4) without ocular or systemic comorbidities
Key exclusion criteria (1 listed)
- history of prior vitrectomy; (2) presence of non-proliferative diabetic retinopathy; (3) coexisting systemic or ocular comorbidities, including, but not limited to, glaucoma, retinal vein occlusion, or rhegmatogenous retinal detachment; and (4) received anti-VEGF therapy within 3 months preceding enrolment.
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 ophthalmic injection （0.5mg）Also: conberceptParticipants were randomly assigned to receive intravitreal injections of either faricimab (IVF, n=4) or conbercept (IVC, n=4) based on a randomisation protocol. To establish a baseline comparison, FVMs were obtained from three treatment-naive patients who served as controls. All participants underwent surgery 4 days after the intravitreal anti-VEGF injections. | Drug | Conbercept (IVC) |
| FaricimabAccording to the randomization protocol, participants were randomly assigned to receive intravitreal injections of faricimab (IVF, n=4) or conbercept (IVC, n=4). To establish a baseline comparison, FVMs were obtained from three treatment-naïve patients as controls. All participants underwent surgery 4 days after intravitreal anti-VEGF injection. | Drug | Faricimab (IVF) |
Primary outcome
Concentration of Anti-VEGF Agents on Angiogenic Factors in FVMs
Time frame: 4 days after injection
VEGF ANG-2
Concentration of of Anti-VEGF Therapy on Myofibroblast Products and Profibrotic Factors in FVMs
Time frame: Four days after the medication injection
Fibronectin（FN1), connective tissue growth factor (CTGF), alpha-smooth muscle actin (α-SMA), and transforming growth factor beta (TGF-β)
Concentration of anti-VEGF treatment on pericyte markers in FVMs
Time frame: Four days after the medication injection
neural glial antigen 2 (NG2), and platelet derived growth factor receptor beta (PDGFR-β)
1 secondary outcome
Rate of Neovascularization on FVMs (SNV/SFVM, %)
Time frame: 1, 2, 3, and 4 days after injection
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 28 Aug 2025.
- Results publication: PubMed 37021018Takahashi N, Abe I, Kira S, Ishii Y. Role of epicardial adipose tissue in human atrial fibrillation. J Arrhythm. 2023 Feb 19;39(2):93-110. doi: 10.1002/joa3.12825. eCollection 2023 Apr.
- Results publication: PubMed 21438852Montero JA, Ruiz-Moreno JM, Correa ME. Intravitreal anti-VEGF drugs as adjuvant therapy in diabetic retinopathy surgery. Curr Diabetes Rev. 2011 May;7(3):176-84. doi: 10.2174/157339911795843104.
- Individual participant dataSharing planned: No. Not considering it for the time being
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ophthalmic injection （0.5mg） and Faricimab in people with Proliferative Diabetic Retinopathy, run by Bojie Hu 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 1 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 28 Aug 2025. 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?
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?
Concentration of Anti-VEGF Agents on Angiogenic Factors in FVMs (time frame: 4 days after injection). 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?
On the ClinicalTrials.gov record for NCT07144865, which also lists 2 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 28 Aug 2025.