A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

PHASE2PHASE3RECRUITING

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME) In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. Approximately 960 participants will be entered in the study.

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Study details:

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME). Approximately 960 participants will be entered in the study. Participants will be randomized 1:1:1 to receive low dose EYE103, high dose EYE103, or 0.

5 mg ranibizumab, administered via intravitreal injection. In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm.

Throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of ETDRS BCVA, examination by slit-lamp biomicroscopy, fundoscopy, and SD-OCT. Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
  • Be male or female ≥18 years of age.
  • Have type 1 or type 2 diabetes mellitus and a HbA1c of ≤12%.
  • Have a decrease in vision in the study eye determined by the investigator to be primarily the result of DME.
  • Exclusion criteria

  • Be pregnant or breastfeeding
  • History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
  • Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening
  • Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
  • If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:
  • Have had prior treatment with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye
  • Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept [2 mg], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-08-14

    Primary completion: 2027-12-31

    Study completion finish: 2027-12-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

      PHASE3

    trial

    Trial ID

    NCT06571045

    Intervention or treatment

    DRUG: Ranibizumab

    DRUG: EYE103

    Conditions

    • Diabetic Macular Edema (DME)

    Find a site

    Closest Location:

    Sydney Retina Clinic

    Research sites nearby

    Select from list below to view details:

    • Sydney Retina Clinic

      Sydney, New South Wales, Australia

    • Sydney, Australia

      Sydney, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: EYE103 Low Dose Treatment Arm
    • EYE103 Low Dose Treatment Arm
    DRUG: EYE103
    • EYE103 is a humanized antibody formulated for intravitreal administration
    EXPERIMENTAL: EYE103 High Dose Treatment Arm
    • EYE103 High Dose Treatment Arm
    DRUG: EYE103
    • EYE103 is a humanized antibody formulated for intravitreal administration
    ACTIVE_COMPARATOR: Ranibizumab Treatment Arm
    • Ranibizumab Treatment Arm
    DRUG: Ranibizumab
    • Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chartChange from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart52 Weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Changes in structural and visual outcomesChanges in structural and visual outcomesDuration of the study, through Week 104

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    References

    Clinical Trials Gov: A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

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