Diabetic Macular Edema (DME)
Conditions
Keywords
Diabetic Macular Edema, DME
Brief summary
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.
Detailed description
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.
Interventions
DRUGEYE103
EYE103 is a humanized antibody formulated for intravitreal administration
DRUGRanibizumab
Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema
Sponsors
EyeBiotech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel enrollment into 1 of 3 arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52 | Baseline and Week 52 | The change from baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52 will be presented. |
| Superiority Hypothesis: Change from Baseline in ETDRS BCVA at Week 52 | 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. |
| Time to Absence of Diabetic Macular Edema (DME) | 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. |
| Time to Gaining ≥15 ETDRS Letters | 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. |
| Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at Week 24 | 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. |
| Proportion of Participants without Intraretinal and Subretinal Fluid at the Foveal Center on OCT at Week 52 | 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. |
| Change from Baseline in Focal Area Zone (FAZ) area on Fluorescein Angiography (FA) at Week 52 | Baseline and Week 52 | The change from baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52 will be presented. |
| Proportion of Participants Achieving 20/40 or Better BCVA at Week 52 | 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. |
| Number of Participants Who Experience an Ocular and/or Systemic Adverse Event (AE) | 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. |
| Number of Participants Who Experience an Ocular and/or Systemic Serious Adverse Event (SAE) | 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. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. |
Countries
Argentina, Brazil, Colombia, Japan, Puerto Rico, United States
Contacts
STUDY_DIRECTORCharles Miller, MD PhD
EyeBiotech Ltd.
Outcome results
None listed