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Compares treatment options for Diabetic Retinopathy (DR)
Official title Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
ClinicalTrials.gov ID: NCT07520045
What this study is testing
What is Faricimab?
Faricimab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic retinopathy (dr).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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 detachment, preretinal fibrosis, vitreomacular traction
- Significant media opacities (e.g., dense cataract, vitreous hemorrhage) precluding reliable OCT/OCTA imaging
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Osijek, Croatia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Osijek, Croatia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.