Diabetic RetinopathyPhase 4NCT06191094
Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy
A Phase 4 study testing Faricimab Injection in people with Diabetic Retinopathy and Vitreous Hemorrhage Due to Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
Trial summary
In this phase IV, randomized, double-masked, sham-controlled study the investigators hope to determine the efficacy in peri-operative faricimab (Vabysmo) compared to sham in limiting complications from pars plana vitrectomy for diabetic vitreous hemorrhage with or without tractional retinal detachments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Vitreous Hemorrhage Due to Diabetes Mellitus
- What is being tested?
- Faricimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2024to Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, 80045
About this study
Official title: A Randomized, Double-masked, Sham-controlled Study to Evaluate the Efficacy of Peri-operative Farcimab in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy
In this phase IV, randomized, double-masked, sham-controlled study the investigators hope to determine the efficacy in peri-operative faricimab (Vabysmo) compared to sham in limiting complications from pars plana vitrectomy for diabetic vitreous hemorrhage with or without tractional retinal detachments.
- Being tested
- Faricimab Injection, sham treatment
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faricimab InjectionDrug
Also called Vabysmo
Pre-operative injection of bevacizumab appears to have mixed results in lowering post-operative vitreous hemorrhage. One potential reason is due to aspiration and removal of medication in the vitreous humor at the time of pars plana vitrectomy leading to less than anticipated results in controlling neovascularization and vitreous hemorrhage post-operatively. To avoid attenuation of our desired effect we plan to repeat faricimab injection post-operatively around week one.
sham treatmentDrug
Patients will be randomized 2:1 to receive either faricimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection
| Study group | Role | What they receive |
|---|---|---|
| Faricimab injection | Experimental | Patients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The 6-mg dose of faricimab will be administered by IVT at the study site to patients. A specified filter needle must be used for each dose preparation of faricimab according to the instructions provided in the Investigator's Brochure and package insert. No other material than specified should be used. Vials of faricimab drug product are for a single-dose only (one injection preparation per patient per eye). Vials used for one patient must not be used for any other patient. Partially used vials, remaining faricimab drug product, as well as administration material must not be reused. Receives: Drug: Faricimab Injection |
| Sham injection | Sham comparator | Patients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The sham procedure mimics an intravitreal injection of faricimab except that the blunt end of an empty syringe is pressed against an anesthetized eye instead of a needle attached to a faricimab-filled syringe. Receives: Drug: sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of post-operative vitreous hemorrhage
Following treatment and surgery, the development of vitreous hemorrhage will be quantified and evaluated.
Measured: 6 months
Secondary outcomes (8)
BCVA outcomes
Vision will be tested following treatment and surgery on the Snellen Chart, with or without correction as indicated.
Measured: 6 and 12 months
Rates of re-operation for non-clearing vitreous hemorrhage
Following treatment and surgery, if re-operation for non-clearing vitreous hemorrhage is indicated, this will be track and quantified.
Measured: 6 and 12 months
Rate of post-operative epiretinal membrane formation.
Following treatment and surgery, the duration of time if a patient was to develop an epiretinal membrane will be quantified and evaluated.
Measured: Through study completion, an average of 1 year
Rate of post-operative rhegmatogenous or tractional retinal detachment.
Following treatment and surgery, the duration of time if a patient was to develop a rhegmatogenous or tractional retinal detachment will be quantified and evaluated.
Measured: Through study completion, an average of 1 year
Duration of operative time.
The official duration of surgical time will be quantified and evaluated.
Measured: intra-operatively
Number of endodiathermy use exchanges intra-operatively.
At the time of surgery, the number of endodiathermy use exchanges will be counted and evaluated.
Measured: intra-operatively
Number of retinal breaks intra-operatively.
At the time of surgery, the number of retinal breaks intra-operatively will be counted and evaluated.
Measured: intra-operatively
Number of patients with intra-operative bleeding
At the time of surgery, the number of patients who experience intra-operative bleeding will be counted and evaluated.
Measured: intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start12 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191094
- Sponsor's protocol ID
- 23-0483
- Status last verified
- May 2026
- First submitted
- 8 Dec 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Sham-controlled Study to Evaluate the Efficacy of Peri-operative Farcimab in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06191094
- Acronym / sponsor ID
- 23-0483
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this phase IV, randomized, double-masked, sham-controlled study the investigators hope to determine the efficacy in peri-operative faricimab (Vabysmo) compared to sham in limiting complications from pars plana vitrectomy for diabetic vitreous hemorrhage with or without tractional retinal detachments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faricimab injection | Experimental | Drug: Faricimab InjectionPatients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The 6-mg dose of faricimab will be administered by IVT at the study site to patients. A specified filter needle must be used for each dose preparation of faricimab according to the instructions provided in the Investigator's Brochure and package insert. No other material than specified should be used. Vials of faricimab drug product are for a single-dose only (one injection preparation per patient per eye). Vials used for one patient must not be used for any other patient. Partially used vials, remaining faricimab drug product, as well as administration material must not be reused. |
| Sham injection | Sham comparator | Drug: sham treatmentPatients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The sham procedure mimics an intravitreal injection of faricimab except that the blunt end of an empty syringe is pressed against an anesthetized eye instead of a needle attached to a faricimab-filled syringe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- ● Patients diagnosed with non-clearing vitreous hemorrhage with or without tractional retinal detachment secondary to proliferative diabetic retinopathy and undergoing pars plana vitrectomy
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faricimab InjectionAlso: VabysmoPre-operative injection of bevacizumab appears to have mixed results in lowering post-operative vitreous hemorrhage. One potential reason is due to aspiration and removal of medication in the vitreous humor at the time of pars plana vitrectomy leading to less than anticipated results in controlling neovascularization and vitreous hemorrhage post-operatively. To avoid attenuation of our desired effect we plan to repeat faricimab injection post-operatively around week one. | Drug | Faricimab injection |
| sham treatmentPatients will be randomized 2:1 to receive either faricimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection | Drug | Sham injection |
Primary outcome
Rates of post-operative vitreous hemorrhage
Time frame: 6 months
Following treatment and surgery, the development of vitreous hemorrhage will be quantified and evaluated.
8 secondary outcomes
BCVA outcomes
Time frame: 6 and 12 months
Rates of re-operation for non-clearing vitreous hemorrhage
Time frame: 6 and 12 months
Rate of post-operative epiretinal membrane formation.
Time frame: Through study completion, an average of 1 year
Rate of post-operative rhegmatogenous or tractional retinal detachment.
Time frame: Through study completion, an average of 1 year
Duration of operative time.
Time frame: intra-operatively
Number of endodiathermy use exchanges intra-operatively.
Time frame: intra-operatively
Number of retinal breaks intra-operatively.
Time frame: intra-operatively
Number of patients with intra-operative bleeding
Time frame: intra-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Faricimab Injection in people with Diabetic Retinopathy and Vitreous Hemorrhage Due to Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of post-operative vitreous hemorrhage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.