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

Conditions

• Diabetic Macular Edema (DME)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab — DRUG
  Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema
• EYE103 — DRUG
  EYE103 is a humanized antibody formulated for intravitreal administration

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) 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.

Key Dates

First listed

Aug 26, 2024

Start date

Aug 7, 2024

Status verified

Jun 2026

Primary completion

Sep 30, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

984 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EYE103 Low Dose Treatment Arm
  EYE103 Low Dose Treatment Arm
• Experimental: EYE103 High Dose Treatment Arm
  EYE103 High Dose Treatment Arm
• Active Comparator: Ranibizumab Treatment Arm
  Ranibizumab Treatment Arm

Primary Outcome Measure

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 ]

Locations (85)

Find similar trials in Scottsdale, AZ

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