A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Subtudy to Evaluate the Safety of Re-Implanting the PDS With Ranibizumab in Participants With DME

Description

This study will evaluate the efficacy, safety, and pharmacokinetics of the PDS with Ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main Study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.

Conditions

Diabetic Macular Edema

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Study Overview

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Study Details

Study overview

This study will evaluate the efficacy, safety, and pharmacokinetics of the PDS with Ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main Study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.

A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda)

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Subtudy to Evaluate the Safety of Re-Implanting the PDS With Ranibizumab in Participants With DME

Condition
Diabetic Macular Edema
Intervention / Treatment

-

Contacts and Locations

Mesa

Barnet Dulaney Perkins Eye Center, Mesa, Arizona, United States, 85206

Phoenix

Retinal Consultants of Arizona;Opthalmology, Phoenix, Arizona, United States, 85014

Phoenix

Arizona Retina and Vitreous Consultants, Phoenix, Arizona, United States, 85016

Phoenix

Associated Retina Consultants, Phoenix, Arizona, United States, 85020

Bakersfield

California Retina Consultants, Bakersfield, California, United States, 93309

Beverly Hills

Retina-Vitreous Associates Medical Group, Beverly Hills, California, United States, 90211

Encino

The Retina Partners, Encino, California, United States, 91436

Fullerton

Retina Consultants of Orange County;Clinical Research, Fullerton, California, United States, 92835

Los Angeles

Jules Stein Eye Institute/ UCLA, Los Angeles, California, United States, 90095

Mountain View

Northern California Retina-Vitreous Associates, Mountain View, California, United States, 94040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2026-11-16