New drug could cut repeat eye surgeries in diabetics
NCT ID NCT06191094
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug farcimab (Vabysmo), given as an injection before and after eye surgery, can reduce bleeding complications in people with diabetes who have bleeding inside the eye. About 100 adults will receive either farcimab or a sham injection. The goal is to see if farcimab lowers the chance of needing another surgery and helps improve vision.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- farcimab (Vabysmo) injection
- What this could lead to
- If it works, this could reduce the need for repeat surgeries and improve vision recovery in diabetic patients with eye bleeding.
- What could go wrong
- This is a small, early-phase trial with only 100 participants. The drug may not reduce bleeding better than sham, and there are risks from the injection itself, such as infection or inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients must meet the following criteria for study entry: * Signed Informed Consent Form * Age ≥ 18 years at time of signing Informed Consent Form * Ability to comply with the study protocol, in the investigator's judgment * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below: * Women must remain abstinent or use contraceptive methods with a failure rate of \<1% per year during the treatment period and for 3 months after the final dose of the study drug. * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). * Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Ocular inclusion criteria for study eye: ● Patients diagnosed with non-clearing vitreous hemorrhage with or without tractional retinal detachment secondary to proliferative diabetic retinopathy and undergoing pars plana vitrectomy Exclusion Criteria: General: Patients who meet any of the following general exclusion criteria will be excluded from study entry: * Any known hypersensitivity to any of the components in the faricimab injection * Any known hypersensitivity to any dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used during the study * History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, or historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the faricimab or that might affect interpretation of the results of the study or renders the patient at high-risk for treatment complications, in the opinion of the investigator * Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab Women of childbearing potential must have a negative urine pregnancy test result at baseline prior to initiation of dosing of faricimab/sham and a negative urine pregnancy test at post-op Week 1 prior to dosing of faricimab/sham Ocular exclusion criteria for study eye: Patients who meet any of the following exclusion criteria for the study eye will be excluded from study entry: * Any ocular anti-VEGF treatment within 3 months prior to Day 1 (Baseline) in the study eye * Vitreous hemorrhage or tractional retinal detachment suspected due to cause other than diabetic retinopathy * Any glaucoma surgery in the study eye prior to the Day 1 (Baseline) visit * History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy in study eye * Uncontrolled glaucoma (e.g., progressive loss of visual fields or defined as intraocular pressure (IOP) ≥25 mmHg at the Day 1 (Baseline) visit despite treatment with anti-glaucoma medication) * Any history of idiopathic, infectious, or noninfectious uveitis * Any current or history of ocular disease other than diabetic retinopathy that may confound assessment of the macula or affect central vision (e.g., age-related macular degeneration, retinal vein occlusion, angioid streaks, histoplasmosis, active or inactive cytomegalovirus retinitis, pathological myopia, retinal detachment, macular traction, retinal embolus, macular hole)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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- AI eye doctor: could software catch diabetic blindness sooner?
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- AI could predict which eye treatments work best for Diabetes-Related vision loss