A Comparative Analysis of OCT and OCT Angiography Biomarkers and Systemic Laboratory Parameters in Patients With Diabetic Retinopathy Undergoing Treatment With Faricimab or Biosimilar Ranibizumab Following Three Loading Doses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of OCT and OCTA biomarkers associated with early anatomical treatment response to faricimab and biosimilar ranibizumab
研究概览
简要总结
The goal of this clinical trial is to see if treatment with faricimab or biosimilar ranibizumab leads to different early imaging changes in adults with diabetic retinopathy requiring anti-VEGF treatment and to identify OCT and OCTA biomarkers predictive of differential early treatment response between the two therapies. The main questions it aims to answer are:
Which OCT and OCT angiography biomarkers predict early treatment response? How do imaging biomarkers change after three loading doses of treatment? Are imaging biomarkers associated with systemic laboratory parameters? Researchers will compare faricimab to biosimilar ranibizumab to see if there are differences in imaging biomarkers and early treatment response.
Participants will:
- be randomized in a 1:1 ratio using a computer-generated randomization sequence
- undergo comprehensive ophthalmic examinations, including visual acuity and intraocular pressure measurement
- undergo OCT and OCT angiography imaging at each visit
- receive three intravitreal injections during the loading phase
- attend follow-up visits from baseline to 4-5 weeks after the third injection
- provide blood samples for systemic laboratory analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years
- •Diabetic retinopathy with or without central macular edema
- •Indication for intravitreal anti-VEGF therapy according to current clinical guidelines
- •Ability to provide written informed consent
排除标准
- •Intravitreal anti-VEGF or corticosteroid treatment in the study eye within 5 months prior to enrollment
- •Any intraocular surgery (including cataract surgery) 3 months prior intraocular surgery to enrollment
- •Retinal laser photocoagulation in the study eye within 3 months prior to enrollment
- •Presence of other ocular, retinal or macular diseases that may affect OCT/OCTA findings or visual acuity (e.g., age-related macular degeneration, retinal vascular occlusions)
- •Retinal detachment, preretinal fibrosis, vitreomacular traction
- •Significant media opacities (e.g., dense cataract, vitreous hemorrhage) precluding reliable OCT/OCTA imaging
- •Uncontrolled glaucoma (intraocular pressure > 30 mmHg in study eye)
- •Active ocular inflammation
- •Suspected active ocular infection in either eye
- •Any febrile illness within 1 week prior to first injection
- •History or presence of any clinically significant disease, non-diabetic metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the opinion of the investigator, may contraindicate treatment with faricimab or biosimilar ranibizumab, interfere with the interpretation of study results, or place the participant at increased risk of treatment-related complications.
- •Women who are pregnant, breastfeeding, or planning pregnancy within the next 100 weeks
- •Known hypersensitivity to faricimab or biosimilar ranibizumab or any of its excipients
- •Participation in another clinical trial that may affect study outcomes
- •Inability to comply with study procedures or follow-up
研究组 & 干预措施
Biosimilar Ranibizumab
Participants will receive intravitreal biosimilar ranibizumab 0.5 mg (0.05 mL per injection) administered as 3 loading doses at 4- to 5-week intervals, in accordance with standard clinical practice. Ophthalmic assessments, including visual acuity, OCT and OCT angiography, are performed at each visit, with the final assessment 4-5 weeks after the third injection.
干预措施: Biosimilar ranibizumab (Drug)
Faricimab
Participants will receive intravitreal faricimab 6 mg (0.05 mL per injection) administered as 3 loading doses at 4- to 5-week intervals, in accordance with standard clinical practice. Ophthalmic assessments, including visual acuity, OCT and OCT angiography, are performed at each visit, with the final assessment 4-5 weeks after the third injection.
干预措施: Faricimab (Drug)
结局指标
主要结局
Comparison of OCT and OCTA biomarkers associated with early anatomical treatment response to faricimab and biosimilar ranibizumab
时间窗: From enrollment to 4-5 weeks after the third intravitreal injection
次要结局
- Association between blood-derived laboratory parameters and imaging-based treatment response(From enrollment to 4-5 weeks after the third intravitreal injection)
研究者
Ivanka Maduna
MD, PhD Candidate
Josip Juraj Strossmayer University of Osijek