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

EyeBiotech

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Diabetic Macular Edema (DME)

Treatments: Drug: EYE103; Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06571045

EYE-RES-102

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 960 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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960 participants in 3 patient groups

EYE103 Low Dose Treatment Arm

Experimental group

Description:

EYE103 Low Dose Treatment Arm

Treatment:

Drug: EYE103

EYE103 High Dose Treatment Arm

Experimental group

Description:

EYE103 High Dose Treatment Arm

Treatment:

Drug: EYE103

Ranibizumab Treatment Arm

Active Comparator group

Description:

Ranibizumab Treatment Arm

Treatment:

Drug: Ranibizumab