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

Phase 3Active Not RecruitingNCT06571045

EyeBiotech Ltd.984 enrolled

Overview

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.

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

984

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline and Week 52

Secondary Outcomes

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

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

Time frame: Baseline and Week 52

Superiority Hypothesis: Change from Baseline in ETDRS BCVA at 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.

Time frame: Baseline and Week 52

Time to Absence of Diabetic Macular Edema (DME)

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.

Time frame: Up to approximately Week 104

Time to Gaining ≥15 ETDRS letters

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

Time frame: Up to approximately Week 52

Proportion of Participants with Resolution of Macular Leakage on FA at 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.

Time frame: Up to approximately Week 24

Proportion of Participants Without Intraretinal and Subretinal Fluid at the Foveal Center on OCT at 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.

Time frame: Up to approximately Week 52

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

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

Time frame: Baseline and Week 52

Proportion of Participants Achieving 20/40 or Better BCVA at Week 52

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

Time frame: Up to approximately Week 52

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

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.

Time frame: Up to approximately 104 Weeks

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

Time frame: Up to approximately 104 Weeks

Number of Participants Who Discontinue Study Treatment Due to an AE

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.

Time frame: Up to approximately 104 Weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (183)

Outcomes

Primary Outcomes

Secondary Outcomes