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

PHASE2PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if 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 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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-08-14

Primary completion: 2027-12-31

Study completion finish: 2027-12-31

Study type

TREATMENT

Phase

PHASE2

PHASE3

Trial ID

NCT06571045

Intervention or treatment

DRUG: Ranibizumab

DRUG: EYE103

Conditions

• Diabetic Macular Edema (DME)

Image related to Diabetic Macular Edema (DME)

Condition: Diabetic Macular Edema (DME)
DRUG: Ranibizumab and other drugs
Sydney, New South Wales, Australia and more
Sponsor: EyeBiotech Ltd.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Sydney Retina Clinic

Research sites nearby

Select from list below to view details:

Sydney Retina Clinic
Sydney, New South Wales, Australia
Sydney, Australia
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: EYE103 Low Dose Treatment Arm EYE103 Low Dose Treatment Arm	DRUG: EYE103 EYE103 is a humanized antibody formulated for intravitreal administration
EXPERIMENTAL: EYE103 High Dose Treatment Arm EYE103 High Dose Treatment Arm	DRUG: EYE103 EYE103 is a humanized antibody formulated for intravitreal administration
ACTIVE_COMPARATOR: Ranibizumab Treatment Arm Ranibizumab Treatment Arm	DRUG: Ranibizumab Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart	Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart	52 Weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Changes in structural and visual outcomes	Changes in structural and visual outcomes	Duration of the study, through Week 104

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

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