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A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm

A Phase III, Multicenter, Randomized Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Retinopathy

NCT04503551•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 ≤12% within 2 months prior to screening or at screening
•Moderately severe or severe NPDR (ETDRS-DRSS level 47 or 53)
•BCVA score of ≥ 69 letters (20/40 approximate Snellen equivalent or better)

Exclusion Criteria

•Uncontrolled blood pressure
•Cerebrovascular accident or myocardial infarction within 6 months prior to randomization
•Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
•Current systemic treatment for a confirmed active systemic infection
•Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
•History of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the patient at high risk for treatment complications in the opinion of the investigator or Sponsor
•Presence of center-involved diabetic macular edema (defined as CST ≥325 µm)
•Any intravitreal anti-VEGF treatment at any time prior to randomization
•Any use of medicated intraocular implants, including Ozurdex® or Iluvien® implants at any time prior to randomization
•Any intravitreal corticosteroid treatment at any time prior to randomization
+12 more criteria

Locations (65)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, United States

Retinal Consultants of Arizona;Opthalmology

Phoenix, Arizona, United States

Associated Retina Consultants

Phoenix, Arizona, United States

California Retina Consultants

Bakersfield, California, United States

The Retina Partners

Encino, California, United States

Retina Consultants of Orange County;Clinical Research

Fullerton, California, United States

Jules Stein Eye Institute/ UCLA

Los Angeles, California, United States

California Eye Specialists Medical Group

Pasadena, California, United States

Kaiser Permanente;RESEARCH AND EVALUATION

Riverside, California, United States

Retina Consultants Medical Group

Sacramento, California, United States

Key Dates

Start Date

August 10, 2020

Primary Completion Date

October 3, 2022

Completion Date

March 2, 2026

Last Updated

February 25, 2026

Enrollment

174

ACTUAL participants

Conditions

Diabetic Retinopathy

Interventions

PDS Implant Pre-Filled with 100 mg/mL Ranibizumab

DRUG

Intravitreal Ranibizumab 0.5 mg Injection

DRUG

Impact of the New Generation Anti-diabetic Drugs on Diabetic Retinopathy

NCT07351786

Diabetes (DM)Retinopathy, Diabetic+2 more

View study

RECRUITINGNA

Clinical Applications of Advanced Ophthalmic Imaging

NCT03135327

Multiple SclerosisDry Eye Syndromes+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm

Inclusion Criteria

Exclusion Criteria

Impact of the New Generation Anti-diabetic Drugs on Diabetic Retinopathy

Clinical Applications of Advanced Ophthalmic Imaging

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