This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab

• Status: Active, not recruiting
• Trial end date: 2024-09-10
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Age ≥18 years at time of signing Informed Consent Form

• Documented diagnosis of diabetes mellitus (Type 1 or Type 2)

• HbA1c level of ≤10% within 2 months prior to screening or at screening

Study eye

• Macular thickening secondary to DME involving the center of the fovea with CST ≥325 um on SD-OCT at screening

• BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent)

Exclusion Criteria:

• High-risk proliferative diabetic retinopathy

• Active intraocular inflammation (grade trace or above)

• Suspected or active ocular or periocular infection of either eye

• Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study

• Cerebrovascular accident or myocardial infarction within 6 months prior to randomization

• Atrial fibrillation diagnosis or worsening within 6 months prior to randomization

• Uncontrolled blood pressure