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Evaluating a new delivery system for treating diabetic macular edema

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)

PHASE3 · Hoffmann-La Roche · NCT04108156

This study is testing a new way to deliver a diabetes eye treatment that lasts longer between doses to see if it works better and is safer than the usual injections.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment634 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche (industry)
Drugs / interventionsranibizumab
Locations92 sites (Mesa, Arizona and 91 other locations)
Trial IDNCT04108156 on ClinicalTrials.gov

What this trial studies

This study assesses the efficacy, safety, and pharmacokinetics of a Port Delivery System (PDS) filled with Ranibizumab for treating diabetic macular edema (DME) compared to standard intravitreal Ranibizumab injections. Participants will receive treatment every 24 weeks, while the control group will receive injections every 4 weeks. Additionally, a substudy will focus on the safety of re-implanting the PDS and the refill-exchange procedures for participants who were previously enrolled in the main study. Up to 100 participants will be followed for a maximum of 72 weeks post-re-implantation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of diabetes and specific visual impairment due to DME.

Not a fit: Patients with high-risk proliferative diabetic retinopathy or uncontrolled ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more convenient and effective treatment option for patients with diabetic macular edema.

How similar studies have performed: Other studies have shown promise with similar delivery systems, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥18 years at time of signing informed consent form (ICF)
* Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
* Glycated haemoglobin (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 micrometer (µm) on SD-OCT at screening
* BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent)

Exclusion Criteria:

* High-risk PDR
* 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

Substudy:

Inclusion Criteria:

* Having experienced a septum dislodgement in the original implant while in the main study or after exiting the main study
* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center

Exclusion Criteria (Cohort 1 Only):

* Recent history (in the last 3 months prior to enrollment) 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 participant at high risk for treatment complications
* Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
* Current systemic treatment for a confirmed active systemic infection
* Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in Study GR40550) within 6 months prior to enrollment
* Use of antimitotic or antimetabolite therapy within 30 days

Ocular Exclusion Criteria for Study Eye:

* Any ocular condition that may render the participant at high risk for surgical or treatment complications
* Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
* Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
* Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
* Concurrent conjunctival, tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant
* Ongoing ocular complications that might affect participant safety Ocular Exclusion Criteria for Either Eye
* Suspected or active ocular or periocular infection (e.g., infectious conjunctivitis or endophthalmitis)
* Any history of uveitis
* Active blepharitis

Where this trial is running

Mesa, Arizona and 91 other locations

+42 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetic Macular Edema, Port Delivery System

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.