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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 (Pagoda)

Primary Purpose

Diabetic Macular Edema

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Intravitreal Ranibizumab 0.5 mg Injection
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Port Delivery System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 ≤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

Sites / Locations

  • Barnet Dulaney Perkins Eye Center
  • Associated Retina Consultants
  • Arizona Retina and Vitreous Consultants
  • Retinal Consultants of Arizona
  • California Retina Consultants
  • Retina-Vitreous Associates Medical Group
  • The Retina Partners
  • Retina Consultants of Orange County
  • N CA Retina Vitreous Assoc
  • East Bay Retina Consultants
  • Doheny Eye Institute
  • California Eye Specialists Medical group Inc.
  • Retinal Consultants Med Group
  • Zuckerberg San Francisco General Hospital
  • Orange County Retina Med Group
  • California Retina Consultants
  • Eye Center of Northern CO
  • Colorado Retina Associates, PC
  • Retina Group of New England
  • Retina Group of Florida
  • National Ophthalmic Research Institute
  • Retina Specialty Institute
  • Fort Lauderdale Eye Institute
  • Retina Vitreous Assoc of FL
  • Southern Vitreoretinal Assoc
  • Retina Associates of Florida, LLC
  • Southeast Retina Center
  • Georgia Retina PC
  • Northwestern Medical Group/Northwestern University
  • Illinois Retina Associates
  • University Retina and Macula Associates, PC
  • Wolfe Eye Clinic
  • Retina Associates
  • Retina Associates of Kentucky
  • Maine Eye Center
  • The Retina Care Center
  • Johns Hopkins Med; Wilmer Eye Inst
  • Retina Group of Washington
  • Cumberland Valley Retina Associates
  • Retina Specialists
  • Tufts Medical Center
  • Ophthalmic Consultants of Boston
  • Associated Retinal Consultants
  • Foundation for Vision Research
  • Vitreo Retinal Surgery
  • Midwest Vision Research Foundation
  • The Retina Institute
  • Sierra Eye Associates
  • Envision Ocular, LLC
  • Mid Atlantic Retina
  • Retina Associates of NJ
  • Long Is. Vitreoretinal Consult
  • Retina Vit Surgeons/Central NY
  • New York University
  • Ophthalmic Cons of Long Island
  • Western Carolina Retinal Associate PA
  • Char Eye Ear &Throat Assoc
  • Duke Eye Center
  • Graystone Eye
  • Cincinnati Eye Institute
  • Cleveland Clinic Foundation; Cole Eye Institute
  • The Ohio State University
  • Midwest Retina
  • Retina Vitreous Center
  • Retina Northwest
  • Cumberland Valley Retina Consultants; Chambersburg
  • Charleston Neuroscience Inst
  • Carolina Eyecare Physicians
  • Palmetto Retina Center, LLC
  • Charles Retina Institute
  • Tennessee Retina PC
  • Retina Res Institute of Texas
  • Texas Retina Associates
  • Austin Retina Associates
  • Austin Research Center for Retina
  • Austin Clinical Research LLC
  • Retina & Vitreous of Texas
  • Texas Retina Associates
  • Texas Retina Associates
  • Med Center Ophthalmology Assoc
  • Retina Consultants of Texas
  • Retina Associates of Utah, PLLC
  • Rocky Mountain Retina
  • Piedmont Eye Center
  • Wagner Kapoor Institute
  • Retina Institute of Virginia
  • Retina Center Northwest
  • Spokane Eye Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PDS Arm

Intravitreal Arm

Arm Description

Participants randomized to the PDS arm will receive intravitreal ranibizumab injection every 4 weeks (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 every 24-weeks (Q24W) thereafter

Participants randomized to the intravitreal arm will receive intravitreal ranibizumab injection every 4 weeks until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64 in the efficacy population
Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64 in the mITT population
Change from baseline in BCVA as measured on the ETDRS chart over time
Percentage of participants who lose <15, <10, and <5 letters in BCVA from baseline over time
Percentage of participants who gain ≥15, ≥10, ≥5, ≥0 letters in BCVA from baseline over time
Percentage of participants with a BCVA Snellen equivalent of 20/40 or better over time
Percentage of participants with a BCVA Snellen equivalent of 20/200 or worse over time
Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS over time
Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS over time
Time to ≥2-step worsening from baseline on the ETDRS-DRSS
Time to ≥3-step worsening from baseline on the ETDRS-DRSS
Change from baseline in ETDRS-DRSS score over time
Change from baseline in CST as measured on SD-OCT over time
Change from baseline in total macular volume as measured on SD-OCT over time
Percentage of participants with absence of intraretinal fluid over time (intraretinal fluid as measured in the central 1 mm subfield)
Percentage of participants with absence of subretinal fluid over time (subretinal fluid as measured in the central 1 mm subfield)
Percentage of participants with absence of intraretinal fluid and subretinal fluid over time
Percentage of participants with absence DME (defined as CST ≥325 μm on SD-OCT) over time
DME = diabetic macular edema
Time to PDR (defined as a score ≥60 on the ETDRS-DRSS)
PDR = proliferative diabetic retinopathy
Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab within each refill-exchange interval
Percentage of participants who report preferring PDS treatment compared with intravitreal ranibizumab treatment
As measured by the PDS Patient Preference Questionnaire at Week 64 among patients in the PDS arm efficacy population, mITT population
Percentage of participants who report preferring PDS treatment compared with intravitreal ranibizumab treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Week 64
Participants in in a subset of patients with bilateral disease who are simultaneously receiving ranibizumab via study eye PDS implant and fellow eye intravitreal injection
Patient-reported vision-related functioning and health-related quality of life (HRQoL) among patients 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
Patient-reported vision-related functioning and HRQoL, as measured by the proportion of patients with a ≥ 4-point improvement from baseline in the NEI VFQ-25 composite score at Weeks 48 and 96 among patients in both treatment arms
Incidence and severity of ocular adverse events
Incidence and severity of non-ocular adverse events
Incidence, severity, and duration of adverse events of special interest
Serum concentration of ranibizumab observed over time
PK parameter value area under the concentration- time curve over 24 weeks (AUC24W)
Pharmacokinetic (PK) parameter maximum serum concentration (Cmax)
PK Parameter minimum serum concentration (Cmin)
Time of maximum observed serum concentration (Tmax) after PDS implant insertion
Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
Prevalence of neutralizing antibodies at baseline and incidence of neutralizing antibodies during the study
Reported incidence of device deficiencies
Incidence and severity of ocular adverse events
Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (up to 37 days after initial implantation) and follow-up period (> 37 days after implantation surgery)
Incidence and severity of adverse device effects
Incidence, causality, severity, and duration of anticipated serious adverse device effects

Full Information

First Posted
September 26, 2019
Last Updated
September 7, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04108156
Brief Title
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
Acronym
Pagoda
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
February 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Port Delivery System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
634 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PDS Arm
Arm Type
Experimental
Arm Description
Participants randomized to the PDS arm will receive intravitreal ranibizumab injection every 4 weeks (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 every 24-weeks (Q24W) thereafter
Arm Title
Intravitreal Arm
Arm Type
Active Comparator
Arm Description
Participants randomized to the intravitreal arm will receive intravitreal ranibizumab injection every 4 weeks until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.
Intervention Type
Drug
Intervention Name(s)
PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Intervention Description
Will be administered as per the schedule described in individual arm.
Intervention Type
Drug
Intervention Name(s)
Intravitreal Ranibizumab 0.5 mg Injection
Intervention Description
Will be administered as per the schedule described in individual arm.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to Week 64
Secondary Outcome Measure Information:
Title
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
Description
ETDRS-DRSS = ETDRS Diabetic Retinopathy Severity Scale
Time Frame
Baseline to Week 64
Title
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
Time Frame
Baseline to Week 64
Title
Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64 in the efficacy population
Time Frame
Baseline to Week 64
Title
Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 64 in the mITT population
Time Frame
Baseline to Week 64
Title
Change from baseline in BCVA as measured on the ETDRS chart over time
Time Frame
Baseline up to Week 120
Title
Percentage of participants who lose <15, <10, and <5 letters in BCVA from baseline over time
Time Frame
Baseline up to Week 120
Title
Percentage of participants who gain ≥15, ≥10, ≥5, ≥0 letters in BCVA from baseline over time
Time Frame
Baseline up to Week 120
Title
Percentage of participants with a BCVA Snellen equivalent of 20/40 or better over time
Time Frame
Baseline up to Week 120
Title
Percentage of participants with a BCVA Snellen equivalent of 20/200 or worse over time
Time Frame
Baseline up to Week 120
Title
Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS over time
Time Frame
Baseline up to Week 120
Title
Percentage of participants with a ≥3-step improvement from baseline on the ETDRS-DRSS over time
Time Frame
Baseline up to Week 120
Title
Time to ≥2-step worsening from baseline on the ETDRS-DRSS
Time Frame
Baseline up to Week 120
Title
Time to ≥3-step worsening from baseline on the ETDRS-DRSS
Time Frame
Baseline up to Week 120
Title
Change from baseline in ETDRS-DRSS score over time
Time Frame
Baseline up to Week 120
Title
Change from baseline in CST as measured on SD-OCT over time
Time Frame
Baseline up to Week 120
Title
Change from baseline in total macular volume as measured on SD-OCT over time
Time Frame
Baseline up to Week 120
Title
Percentage of participants with absence of intraretinal fluid over time (intraretinal fluid as measured in the central 1 mm subfield)
Time Frame
Baseline up to Week 120
Title
Percentage of participants with absence of subretinal fluid over time (subretinal fluid as measured in the central 1 mm subfield)
Time Frame
Baseline up to Week 120
Title
Percentage of participants with absence of intraretinal fluid and subretinal fluid over time
Time Frame
Baseline up to Week 120
Title
Percentage of participants with absence DME (defined as CST ≥325 μm on SD-OCT) over time
Description
DME = diabetic macular edema
Time Frame
Baseline up to Week 120
Title
Time to PDR (defined as a score ≥60 on the ETDRS-DRSS)
Description
PDR = proliferative diabetic retinopathy
Time Frame
Baseline up to Week 120
Title
Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab within each refill-exchange interval
Time Frame
Baseline up to Week 120
Title
Percentage of participants who report preferring PDS treatment compared with intravitreal ranibizumab treatment
Description
As measured by the PDS Patient Preference Questionnaire at Week 64 among patients in the PDS arm efficacy population, mITT population
Time Frame
Baseline to Week 64
Title
Percentage of participants who report preferring PDS treatment compared with intravitreal ranibizumab treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Week 64
Description
Participants in in a subset of patients with bilateral disease who are simultaneously receiving ranibizumab via study eye PDS implant and fellow eye intravitreal injection
Time Frame
Baseline to Week 64
Title
Patient-reported vision-related functioning and health-related quality of life (HRQoL) among patients in both treatment arms, as measured by changes from baseline
Description
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
Time Frame
, Baseline Week 48, Week 96
Title
Patient-reported vision-related functioning and HRQoL, as measured by the proportion of patients with a ≥ 4-point improvement from baseline in the NEI VFQ-25 composite score at Weeks 48 and 96 among patients in both treatment arms
Time Frame
Baseline, Week 48, Week 96
Title
Incidence and severity of ocular adverse events
Time Frame
Baseline to Week 120
Title
Incidence and severity of non-ocular adverse events
Time Frame
Baseline up to Week 120
Title
Incidence, severity, and duration of adverse events of special interest
Time Frame
Baseline up to Week 120
Title
Serum concentration of ranibizumab observed over time
Time Frame
Baseline up to Week 120
Title
PK parameter value area under the concentration- time curve over 24 weeks (AUC24W)
Time Frame
Baseline to Week 24
Title
Pharmacokinetic (PK) parameter maximum serum concentration (Cmax)
Time Frame
Baseline up to Week 120
Title
PK Parameter minimum serum concentration (Cmin)
Time Frame
Baseline up to Week 120
Title
Time of maximum observed serum concentration (Tmax) after PDS implant insertion
Time Frame
Baseline up to Week 120
Title
Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
Time Frame
Baseline up to Week 120
Title
Prevalence of neutralizing antibodies at baseline and incidence of neutralizing antibodies during the study
Time Frame
Baseline up to Week 120
Title
Reported incidence of device deficiencies
Time Frame
Baseline up to Week 120
Title
Incidence and severity of ocular adverse events
Time Frame
Baseline up to Week 120
Title
Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (up to 37 days after initial implantation) and follow-up period (> 37 days after implantation surgery)
Time Frame
Baseline up to Week 120
Title
Incidence and severity of adverse device effects
Time Frame
Baseline up to Week 120
Title
Incidence, causality, severity, and duration of anticipated serious adverse device effects
Time Frame
Baseline up to Week 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Barnet Dulaney Perkins Eye Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Arizona Retina and Vitreous Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
The Retina Partners
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835-3424
Country
United States
Facility Name
N CA Retina Vitreous Assoc
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
East Bay Retina Consultants
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Doheny Eye Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
California Eye Specialists Medical group Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Retinal Consultants Med Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Orange County Retina Med Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Eye Center of Northern CO
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Colorado Retina Associates, PC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Retina Group of New England
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Fort Lauderdale Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Retina Vitreous Assoc of FL
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Southern Vitreoretinal Assoc
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Retina Associates of Florida, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Georgia Retina PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1137
Country
United States
Facility Name
Northwestern Medical Group/Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Illinois Retina Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
University Retina and Macula Associates, PC
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Retina Associates
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Maine Eye Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
The Retina Care Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Johns Hopkins Med; Wilmer Eye Inst
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Cumberland Valley Retina Associates
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Retina Specialists
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Associated Retinal Consultants
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Foundation for Vision Research
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Vitreo Retinal Surgery
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Midwest Vision Research Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Envision Ocular, LLC
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Mid Atlantic Retina
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Retina Associates of NJ
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Long Is. Vitreoretinal Consult
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
Facility Name
Retina Vit Surgeons/Central NY
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Ophthalmic Cons of Long Island
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Western Carolina Retinal Associate PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Char Eye Ear &Throat Assoc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Graystone Eye
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Cleveland Clinic Foundation; Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Midwest Retina
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Retina Vitreous Center
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Retina Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Facility Name
Cumberland Valley Retina Consultants; Chambersburg
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Charleston Neuroscience Inst
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Carolina Eyecare Physicians
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Palmetto Retina Center, LLC
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Charles Retina Institute
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Tennessee Retina PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Retina Res Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-1169
Country
United States
Facility Name
Austin Research Center for Retina
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Austin Clinical Research LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Retina & Vitreous of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Retina Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Med Center Ophthalmology Assoc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of Texas
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384-4167
Country
United States
Facility Name
Retina Associates of Utah, PLLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Rocky Mountain Retina
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Wagner Kapoor Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Retina Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Retina Center Northwest
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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