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

NCT07144865 | Completed

• 3 other identifiers: TianjinMUEHhbj100Not providednot provided
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (3)

• Concentration of Anti-VEGF Agents on Angiogenic Factors in FVMs

  VEGF ANG-2

  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)

  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)

  Four days after the medication injection

Secondary Outcomes (1)

• Rate of Neovascularization on FVMs (SNV/SFVM, %)

  1, 2, 3, and 4 days after injection

Study Arms (2)

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.

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.

Drug: conbercept ophthalmic injection （0.5mg）

Interventions

conbercept ophthalmic injection （0.5mg） 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.

Also known as: conbercept

Conbercept (IVC)

Faricimab 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.

Faricimab (IVF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Bojie Hu: lead

Study Sites (1)

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, 300000, China

Location

Related Publications (2)

• 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.

  PMID: 37021018 BACKGROUND

• 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.

  PMID: 21438852 BACKGROUND

MeSH Terms

Interventions

KH902 fusion protein; faricimab

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 28, 2025
• Study Start: December 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)