Biological Changes in Fibrovascular Membranes of Patients With Proliferative Diabetic Retinopathy Following Faricimab Injection

NCT ID: NCT07144865

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-04-01

Brief 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. 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.

Conditions

Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Faricimab (IVF)

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.

Group Type: ACTIVE_COMPARATOR

Faricimab

Intervention Type: DRUG

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.

Conbercept (IVC)

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.

Group Type: ACTIVE_COMPARATOR

conbercept ophthalmic injection （0.5mg）

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Faricimab

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.

Intervention Type: DRUG

Other Intervention Names

conbercept

Eligibility Criteria

Inclusion Criteria

(1) 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

Exclusion Criteria

(1) 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bojie Hu

OTHER

Sponsor Role: lead

Responsible Party

Bojie Hu

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 37021018 (View on PubMed)

Montero 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.

Reference Type: BACKGROUND

PMID: 21438852 (View on PubMed)

Other Identifiers

Not provided

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

not provided

Identifier Type: OTHER

Identifier Source: secondary_id

TianjinMUEHhbj100

Identifier Type: -

Identifier Source: org_study_id