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NCT Number: NCT06957080

A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

EYE-RES-103 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetic Macular Edema (DME)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Buenos Aires, Argentina, Buenos Aires, Argentina

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About this study

EYE-RES-103 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 Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA), examination by slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT). Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 hemoglobin A1c (HbA1c) of ≤12%.
  • Have a decrease in vision in the study eye determined by the investigator to be primarily the result of diabetic macular edema (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 in the study eye with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit
  • Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept [2 mg], pegaptanib sodium) in the study eye within 90 days of the Screening visit

Treatment and study plan

EYE103

Drug

EYE103 is a humanized antibody formulated for intravitreal administration

Other names: Restoret

ranibizumab

Drug

Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema

Other names: Lucentis

Primary outcomes

  1. Change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart

    Time frame: Baseline and Week 52

    The change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.

Secondary outcomes

  1. Proportion of participants who gain ≥15 ETDRS letters in BCVA at Week 52

    Time frame: Up to approximately Week 52

    The proportion of participants who chain ≥15 letters on the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart in Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.

  2. Time to gaining ≥15 ETDRS letters

    Time frame: Up to approximately Week 52

    The time to gaining ≥15 letters on the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.

  3. Change from Baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52

    Time frame: Baseline and Week 52

    The change from baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52 will be presented.

  4. Change from Baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52

    Time frame: Baseline and Week 52

    The change from baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52 will be presented.

  5. Superiority Hypothesis: Change from Baseline in ETDRS BCVA at Week 52

    Time frame: Baseline and Week 52

    The Superiority Hypothesis: change from baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.

  6. Time to absence of Diabetic Macular Edema (DME)

    Time frame: Up to approximately Week 52

    The time to absence of Diabetic Macular Edema (DME) defined as Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) of <300 μm will be presented.

  7. Proportion of participants with resolution of macular leakage on FA at Week 24

    Time frame: Up to approximately Week 24

    The proportion of participants with resolution of macular leakage on fluorescein angiography (FA), defined as 0 to 1 mm^2, at Week 24 will be presented.

  8. Proportion of participants without intraretinal and subretinal fluid at the foveal center on OCT at Week 52

    Time frame: Up to approximately Week 52

    The proportion of participants without intraretinal and subretinal fluid at the foveal center on Optical Coherence Tomography (OCT) at Week 52 will be presented.

  9. Proportion of participants who gain ≥5 ETDRS letters in BCVA at Week 52

    Time frame: Up to approximately Week 52

    The proportion of participants who gain ≥5 letters on the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart in Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.

  10. Proportion of participants achieving 20/40 or better BCVA at Week 52

    Time frame: Up to approximately Week 52

    The proportion of participants who achieve 20/40 or better Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.

  11. Number of Participants Who Experience an Ocular and/or Systemic Adverse Event (AE)

    Time frame: Up to approximately 104 Weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic AE will be reported.

  12. Number of Participants Who Experience an Ocular and/or Systemic Serious Adverse Event (SAE)

    Time frame: Up to approximately 104 Weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic serious adverse event (SAE) will be reported.

  13. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 104 Weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

EyeBiotech Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Masked, Multi-Center, 3-Arm Pivotal Phase 2/3 Study to Evaluate The Efficacy and Safety of Intravitreal EYE103 Compared With Intravitreal Ranibizumab (0.5mg) in Participants With Diabetic Macular Edema

Acronym: BAROLO

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 4, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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