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Study of Faricimab treatment to improve vision in patients with diabetic macular edema using adaptive optics imaging

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies the treatment of diabetic macular edema, a condition where fluid builds up in the macula (the central part of the retina) due to diabetes, causing vision problems. The study uses faricimab (Vabysmo), which is given as an injection solution into the eye. This medication works by targeting specific proteins that contribute to blood vessel problems in the eye.

The main purpose of this study is to determine how well faricimab improves vision in patients with diabetic macular edema over a 12-month period. The study will measure improvements in vision using specialized eye tests and examine changes in the blood vessels of the eye. The medication will be administered through eye injections, with the frequency of treatments varying between every 4, 8, 12, or 16 weeks, depending on how each patient responds to the treatment.

During the study, participants will receive Vabysmo injections containing 120 mg/mL of the medication. The treatment period lasts for 12 months, during which patients will have regular eye examinations to monitor their vision and the condition of their eyes. Various advanced imaging techniques will be used to examine the detailed structure of the eye and measure how well the treatment is working.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will receive an eye examination to measure your visual acuity using special charts (ETDRS charts) from 4 meters distance

    Your doctor will check your blood sugar control by measuring HbA1c level

    A detailed examination of your eyes will be performed to confirm diabetic macular edema (swelling in the central part of the retina)

  2. Step 2

    Treatment initiation

    You will receive Vabysmo (faricimab) as an injection into your eye

    The medication comes as a solution containing 120 mg/mL

    The injection will be performed by an eye care specialist

  3. Step 3

    Treatment schedule

    Your treatment intervals will be determined based on your eye condition

    Injections may be given every 4, 8, 12, or 16 weeks

    The schedule will be adjusted according to how your eye responds to treatment

  4. Step 4

    Regular monitoring

    Your vision will be tested regularly using standard eye charts

    Special imaging tests will be performed to measure the swelling in your retina

    The doctor will check for the presence of fluid in different layers of your retina

  5. Step 5

    Final assessment

    After 12 months of treatment, your final vision test will be performed

    The doctor will compare your vision and eye condition with the measurements taken at the start

    The total number of injections you received during the 12-month period will be recorded

Who can join the trial?

6 criteria

  • Patient must sign an informed consent form, which is a document explaining all aspects of the study
  • Patient must be 18 years of age or older
  • Both men and women can participate
  • Patient's HbA1c level (a blood test that measures average blood sugar over the past 2-3 months) must be 16% or less
  • Patient's vision in the study eye must be better than 25 letters when tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart (this is a special chart used to measure vision in clinical trials)
  • Patient's vision measurement must correspond to 1.2 VAlogMAR (this is another way of measuring vision using a different scale)

Who cannot join the trial?

12 criteria

  • Active or suspected ocular infection (inflammation of the eye) or active inflammation in either eye
  • History of retinal detachment (separation of the light-sensitive layer of the eye from its supporting tissue) in either eye
  • Uncontrolled blood pressure (blood pressure readings consistently above 140/90)
  • History of stroke or heart attack within the past 3 months
  • Pregnant women or women planning pregnancy during the study period
  • Current participation in other clinical trials or use of investigational drugs
  • Previous eye surgery within 3 months before the start of the study
  • Known allergies to the study medication or its components
  • Significant eye disease other than diabetic macular edema that could interfere with the study assessments
  • Unable to comply with study procedures or follow-up visits
  • History of blood clotting disorders or current use of blood thinners
  • Active or recent vitreous hemorrhage (bleeding inside the eye) within the past month
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Investigated drugs

Faricimab is a medication used to treat diabetic macular edema, which is a condition where fluid builds up in the macula (central part of the retina) due to diabetes. This medicine works by targeting and blocking two different pathways that cause blood vessels to leak and grow abnormally in the eye. It is administered as an injection directly into the eye by a healthcare professional. The medication helps improve vision and reduce swelling in patients with diabetic macular edema.

What is already known about the treatment

Faricimab - A bispecific antibody medication administered through intravitreal injection (directly into the eye) used for treating diabetic macular edema, which is a condition causing swelling in the retina. This innovative drug works by simultaneously targeting and inhibiting two distinct pathways (VEGF and Ang-2) involved in blood vessel growth and inflammation in the eye, making it the first medication of its kind in ophthalmology. As a Phase IV medication, it has already received regulatory approval and is being studied in post-marketing clinical trials to further understand its effectiveness and relationship with visual acuity improvements. Faricimab belongs to the pharmacological class of ophthalmologic agents and antiangiogenic drugs, representing an advancement in the treatment of retinal diseases.

Investigated diseases

  • Macular Edema

    A condition where fluid accumulates in the macula, the central part of the retina responsible for detailed vision. The buildup of fluid causes the macula to swell and thicken, which distorts vision in the center of the visual field. This condition commonly occurs as a complication of diabetes, where it is specifically known as diabetic macular edema. The swelling can lead to blurred or distorted central vision, while peripheral vision typically remains unchanged. As the condition progresses, it may cause difficulty with reading, recognizing faces, or performing detailed tasks.

  • Diabetic Macular Edema

    A specific type of macular edema that occurs in people with diabetes when damaged blood vessels in the retina begin to leak fluid into the macula. The condition develops when high blood sugar levels damage the tiny blood vessels in the retina, causing them to become weak and permeable. As these vessels leak fluid into the macula, the central part of the retina swells, leading to vision problems. The condition typically develops gradually and affects both eyes, though not necessarily at the same rate or severity.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509829-52-00Protocol codeKKSH193Estimated enrolment133 patientsSponsorMartin-Luther-Universitaet Halle-Wittenberg

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