Active, not recruitingNCT06571045ClinicalTrials.gov record

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

Diabetic Macular Edema (DME)

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 2 / Phase 3
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 984 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (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 remigromig 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.

Read the full description

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig 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 remigromig, high dose remigromig, 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 remigromig 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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean 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 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

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Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Quadruple masked

Remigromig Low Dose Treatment Arm

Drug: Remigromig

Remigromig High Dose Treatment Arm

Drug: Remigromig

Ranibizumab Treatment Arm

Drug: Ranibizumab

Ranibizumab DRUG

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

Remigromig DRUG

Remigromig is a humanized antibody formulated for intravitreal administration

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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 measures

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.

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.

Time to Absence of Diabetic Macular Edema (DME)

Time frame: Up to approximately Week 104

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

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.

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.

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.

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.

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.

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.

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

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (183)

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Find a location in this study

183 locations

ScottsdaleScottsdale, Arizona, United StatesStatus unknown

What this study involves

About the research

Who may be able to participate?

Treatment, groups and participation

What researchers are measuring

Primary measures

Secondary measures

Research locations (183)

Study team and timeline

Official study contacts

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