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 Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME (Pagoda)

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)

This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab; Drug: Intravitreal Ranibizumab 0.5 mg Injection; Drug: Ranibizumab refill exchange

• Study Type: Interventional
• Enrollment (Actual): 672
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Barnet Dulaney Perkins Eye Center
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants
    • Phoenix, Arizona, United States, 85016
      • Arizona Retina and Vitreous Consultants
    • Phoenix, Arizona, United States, 85014
      • Retinal Consultants of Arizona;Opthalmology
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Consultants
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Encino, California, United States, 91436
      • The Retina Partners
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County;Clinical Research
    • Los Angeles, California, United States, 90095
      • Jules Stein Eye Institute/ UCLA
    • Mountain View, California, United States, 94040
      • Northern California Retina-Vitreous Associates
    • Oakland, California, United States, 94609
      • East Bay Retina Consultants
    • Pasadena, California, United States, 91105
      • Doheny Eye Institute
    • Pasadena, California, United States, 91107
      • California Eye Specialists Medical Group
    • Sacramento, California, United States, 95841
      • Retina Consultants Medical Group
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital and Trauma Center
    • Santa Ana, California, United States, 92705
      • Orange County Retina Medical Group
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants;Research Department
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Eye Center of Northern Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Clinical Research
  • Connecticut
    • Waterford, Connecticut, United States, 06385
      • Retina Group of New England
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Retina Group of Florida
    • Fort Myers, Florida, United States, 33912
      • National Ophthalmic Research Institute
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Plantation, Florida, United States, 33324
      • Fort Lauderdale Eye Institute
    • St. Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida
    • Tallahassee, Florida, United States, 32308
      • Southern Vitreoretinal Associates;Research
    • Tampa, Florida, United States, 33609
      • Retina Associates of Florida;Retina Associates of Florida
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center
    • Marietta, Georgia, United States, 30060
      • Georgia Retina
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Joliet, Illinois, United States, 60435
      • Illinois Retina Associates
    • Lemont, Illinois, United States, 60439
      • University Retina
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • Retina Associates
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Retina & Vitreous Associates of Kentucky
  • Maine
    • Portland, Maine, United States, 04605
      • Maine Eye Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital;Johns Hopkins Med;Wilmer Eye Inst
    • Chevy Chase, Maryland, United States, 20815
      • The Retina Group of Washington;Retinal Disease
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants;Clinical Research
    • Towson, Maryland, United States, 21204
      • Retina Specialist
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Worcester, Massachusetts, United States, 01605
      • Vitreo Retinal Associates
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Retina Specialists Of Michigan
    • Royal Oak, Michigan, United States, 48073
      • Associated Retinal Consultants - Royal Oak
  • Minnesota
    • Minneapolis, Minnesota, United States, 55435
      • VitreoRetinal Surgery PLLC;DBA Retina Consultants of Minnesota
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Pepose Vision Institute
    • St Louis, Missouri, United States, 63128
      • Retina Institute
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • Envision Ocular, LLC
    • Teaneck, New Jersey, United States, 07666
      • Retina Associates of New Jersey
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Vitreoretinal Consultants;Opthalmology
    • Liverpool, New York, United States, 13088
      • Retina Vitreous Surgeons of Central New York
    • New York, New York, United States, 10017
      • New York University (NYU)
    • Oceanside, New York, United States, 11572
      • Ophthalmic Consultants of Long Island
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Eye Associates Western Carolina Retinal Associates;Clinical Research
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose and Throat Associates- SouthPark;Retina
    • Durham, North Carolina, United States, 27705
      • Duke Eye Center
    • Hickory, North Carolina, United States, 28602
      • Graystone Eye;Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute;Retina
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43212
      • Ohio State Havener Eye Institute;Ophthalmology Research
    • Dublin, Ohio, United States, 43016
      • Midwest Retina;Retina/Vitreous
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Retina Vitreous Center - Glen Eagles
  • Oregon
    • Portland, Oregon, United States, 97221
      • Retina Northwest;Research Department
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience
    • Mt. Pleasant, South Carolina, United States, 29464
      • Carolina Eyecare Physicians
    • West Columbia, South Carolina, United States, 29169
      • Palmetto Retina Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Charles Retina Institution;Retina surgery
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas
    • Arlington, Texas, United States, 76012
      • Texas Retina Associates
    • Austin, Texas, United States, 78705
      • Austin Research Center for Retina
    • Austin, Texas, United States, 78750
      • Austin Clinical Research, LLC
    • Austin, Texas, United States, 78705
      • Austin Retina Associates;Opthalmology
    • Bellaire, Texas, United States, 77401
      • Retina & Vitreous of Texas
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates;Research
    • Fort Worth, Texas, United States, 76104
      • Texas Retina Associates
    • Houston, Texas, United States, 77401
      • Retina Consultants of Texas
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
  • Utah
    • Murray, Utah, United States, 84107
      • Rocky Mountain Retina Consultants
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah, PLLC;Clinical Research
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center
    • Norfolk, Virginia, United States, 23502
      • Wagner Kapoor Institute;Opthalmology
    • Richmond, Virginia, United States, 23235
      • Retina Institute of Virginia
  • Washington
    • Silverdale, Washington, United States, 98383
      • Pacific Northwest Retina
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research;Spokane Eye Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PDS Arm; Participants randomized to the PDS arm will receive IVT ranibizumab injection Q4W (loading phase) and will then have the PDS implant (pre-filled with ranibizumab) surgically inserted. PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.	Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab; Will be administered as per the schedule described in individual arm.; Drug: Ranibizumab refill exchange; Will be administered as per the schedule described in individual arm.
Active Comparator: Intravitreal Arm; Participants randomized to the intravitreal arm will receive IVT ranibizumab injection Q4W until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.	Drug: Intravitreal Ranibizumab 0.5 mg Injection; Will be administered as per the schedule described in individual arm.; Drug: Ranibizumab refill exchange; Will be administered as per the schedule described in individual arm.
Experimental: Substudy: Cohort 1; Participants will undergo re-implantation with the updated PDS implant (pre-filled with ranibizumab 100 milligrams per milliliter [mg/mL]) on Day 1 (or enrollment visit) and then will have two refill-exchanges (ranibizumab 100 mg/mL) Q24W up to 48 weeks.	Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab; Will be administered as per the schedule described in individual arm.; Drug: Ranibizumab refill exchange; Will be administered as per the schedule described in individual arm.
Experimental: Substudy: Cohort 2a; Participants who received an updated PDS implant, have < 24 weeks post-re-implantation follow-up and no scheduled refill-exchange visit in the main study, will undergo two refill-exchange procedures (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit.	Drug: Ranibizumab refill exchange; Will be administered as per the schedule described in individual arm.
Experimental: Substudy: Cohort 2b; Participants who received an updated PDS implant, have < 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, regardless of whether the refill exchange was administered or the visit was missed, will undergo one refill-exchange procedure (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit.	Drug: Ranibizumab refill exchange; Will be administered as per the schedule described in individual arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substudy: Duration of AESIs		Baseline to Week 72
Substudy: Duration of Ocular AESIs During the Post-operative Period		Up to Day 37 post re-implantation
Substudy: Duration of Ocular AESIs During the Follow-up Period		> 37 days post-implantation (up to approximately 72 weeks)
Substudy: Duration of Serious ADEs		Baseline to Week 72
Substudy: Number of Device Deficiencies		Baseline to Week 72
Change in BCVA Score From Baseline Averaged Over Weeks 60 and 64 as Measured Using the ETDRS Chart in the Efficacy Population Using a Treatment Policy Strategy for all Intercurrent Events	BCVA = Best-Corrected Visual Acuity ETDRS = Early Treatment Diabetic Retinopathy Study A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.	Baseline to Week 64
Substudy: Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of Ocular and Systemic AEs		Baseline to Week 72
Substudy: Number of Participants With Adverse Events of Special Interests (AESIs) and Severity of AESIs		Baseline to Week 72
Substudy: Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period		Up to Day 37 post re-implantation
Substudy: Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period		> 37 days post-implantation (up to approximately 72 weeks)
Substudy: Number of Participants With Adverse Device Effects (ADEs) and Severity of ADEs		Baseline to Week 72
Substudy: Number of Participants With Anticipated Serious ADEs		Baseline to Week 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in BCVA as Measured on the ETDRS Chart Over Time		Baseline up to Week 120
Time to PDR (Defined as a Score ≥60 on the ETDRS-DRSS)	PDR = proliferative diabetic retinopathy	Baseline up to Week 120
Serum Concentration of Ranibizumab Observed Over Time		Baseline up to Week 120
Time of Maximum Observed Serum Concentration (Tmax) After PDS Implant Insertion		Baseline up to Week 120
Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study		Baseline up to Week 120
Prevalence of Neutralizing Antibodies at Baseline and Incidence of Neutralizing Antibodies During the Study		Baseline up to Week 120
Reported Incidence of Device Deficiencies		Baseline up to Week 120
Incidence and Severity of ADEs		Baseline up to Week 120
Substudy: Duration of AESIs After Refill-exchange Procedure		Up to approximately 72 weeks
Substudy: Number of Participants With ADEs and Severity of ADEs After Refill-exchange Procedure		Up to approximately 72 weeks
Substudy: Duration of Serious ADEs After Refill-exchange Procedure		Up to approximately 72 weeks
Substudy: Number of Device Deficiencies After Refill-exchange Procedure		Up to approximately 72 weeks
Change in BCVA Score From Baseline Averaged Over Weeks 60 and 64 as Measured With Use of the ETDRS Chart in the Modified Intent-to-treat (mITT) Population Using a Treatment Policy Strategy for All Intercurrent Events	ETDRS-DRSS = ETDRS Diabetic Retinopathy Severity Scale	Baseline to Week 64
Change in BCVA Score From Baseline Averaged Over Weeks 60 and 64 as Measured With Use of the ETDRS Chart in the mITT Population Using a Hypothetical Strategy for All Intercurrent Events		Baseline to Week 64
Percentage of Participants With a ≥2-step Improvement From Baseline on the ETDRS-DRSS at Week 64 in the Efficacy Population		Baseline to Week 64
Percentage of Participants With a ≥2-step Improvement From Baseline on the ETDRS-DRSS at Week 64 in the mITT population		Baseline to Week 64
Percentage of Participants Who Lose <15, <10, and <5 letters in BCVA From Baseline Over Time		Baseline up to Week 120
Percentage of Participants Who Gain ≥15, ≥10, ≥5, ≥0 Letters in BCVA From Baseline Over Time		Baseline up to Week 120
Percentage of Participants With a BCVA Snellen Equivalent of 20/40 or Better Over Time		Baseline up to Week 120
Percentage of Participants With a BCVA Snellen Equivalent of 20/200 or Worse Over Time		Baseline up to Week 120
Percentage of Participants With a ≥2-step Improvement From Baseline on the ETDRS-DRSS Over Time		Baseline up to Week 120
Percentage of Participants With a ≥3-step Improvement From Baseline on the ETDRS-DRSS Over Time		Baseline up to Week 120
Time to ≥2-step Worsening From Baseline on the ETDRS-DRSS		Baseline up to Week 120
Time to ≥3-step Worsening From Baseline on the ETDRS-DRSS		Baseline up to Week 120
Change From Baseline in ETDRS-DRSS Score Over Time		Baseline up to Week 120
Change From Baseline in Central Subfield Thickness (CST) as Measured on Spectral Domain Optical Coherence Tomography (SD-OCT) Over Time		Baseline up to Week 120
Change From Baseline in Total Macular Volume as Measured on SD-OCT Over Time		Baseline up to Week 120
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time (IRF as Measured in the Central 1 mm Subfield)		Baseline up to Week 120
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time (SRF as Measured in the Central 1 mm Subfield)		Baseline up to Week 120
Percentage of Participants With Absence of IRF and SRF Over Time		Baseline up to Week 120
Percentage of Participants With Absence DME (Defined as CST ≥325 μm on SD-OCT) Over Time	DME = diabetic macular edema	Baseline up to Week 120
Percentage of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Within Each Refill-exchange Interval		Baseline up to Week 120
Percentage of Participants Who Report Preferring PDS Treatment Compared With IVT Ranibizumab Treatment	As measured by the PDS patient preference questionnaire (PPPQ) at Week 64 among participants in the PDS arm efficacy population, mITT population	Baseline to Week 64
Percentage of Participants Who Report Preferring PDS Treatment Compared With IVT Ranibizumab Treatment, as Measured by the PPPQ at Week 64	Participants in a subset of patients with bilateral disease who are simultaneously receiving ranibizumab via study eye PDS implant and fellow eye IVT injection.	Baseline to Week 64
Participant-reported Vision-related Functioning and Health-Related Quality of Life (HRQoL) Among Participants in Both Treatment Arms, as Measured by Changes From Baseline	As measured by in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) composite score and Near Activities, Distance Activities, and Driving subscale scores	, Baseline Week 48, Week 96
Participant-reported Vision-related Functioning and HRQoL, as Measured by the Proportion of Participants With a ≥ 4-Point Improvement From Baseline in the NEI VFQ-25 Composite Score at Weeks 48 and 96 Among Participants in Both Treatment Arms		Baseline, Week 48, Week 96
Incidence and Severity of Ocular AEs		Baseline to Week 120
Incidence and Severity of Non-ocular AEs		Baseline up to Week 120
Incidence, Severity, and Duration of AEs of Special Interest		Baseline up to Week 120
PK Parameter: Value Area Under the Concentration- Time Curve Over 24 weeks (AUC24W)		Baseline to Week 24
PK Parameter: Maximum Serum Concentration (Cmax)		Baseline up to Week 120
PK Parameter: Minimum Serum Concentration (Cmin)		Baseline up to Week 120
Incidence and Severity of Ocular AEs		Baseline up to Week 120
Incidence, Severity, and Duration of AESIs		Baseline up to Week 120
Incidence, Severity, and Duration of Ocular AESIs During the Postoperative Period (up to 37 Days After Initial Implantation) and Follow-up Period (> 37 days After Implantation Surgery)		Baseline up to Week 120
Incidence, Causality, Severity, and Duration of Anticipated Serious ADEs		Baseline up to Week 120
Substudy: Number of Participants With Ocular AESIs and Severity of Ocular AESIs After Refill-exchange Procedure		Up to approximately 72 weeks
Substudy: Number of Participants With Anticipated Serious ADEs After Refill-exchange Procedure		Up to approximately 72 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Khanani AM, Campochiaro PA, Graff JM, Marcus DM, Miller D, Mittra RA, Regillo C, Sheth VS, Bobbala A, Gune S, Lin S, Quezada-Ruiz C, Malhotra V. Continuous Ranibizumab via Port Delivery System vs Monthly Ranibizumab for Treatment of Diabetic Macular Edema: The Pagoda Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 1;143(4):326-335. doi: 10.1001/jamaophthalmol.2025.0006.
• Stockwell AD, Chang MC, Mahajan A, Forrest W, Anegondi N, Pendergrass RK, Selvaraj S, Reeder J, Wei E, Iglesias VA, Creps NM, Macri L, Neeranjan AN, van der Brug MP, Scales SJ, McCarthy MI, Yaspan BL. Multi-ancestry GWAS analysis identifies two novel loci associated with diabetic eye disease and highlights APOL1 as a high risk locus in patients with diabetic macular edema. PLoS Genet. 2023 Aug 16;19(8):e1010609. doi: 10.1371/journal.pgen.1010609. eCollection 2023 Aug.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Port Delivery System
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Edema; Macular Edema; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Drug Administration Routes; Drug Therapy; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ranibizumab; Injections
• Other Study ID Numbers: GR40550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No