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A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration (Archway)

Primary Purpose

Neovascular Age-Related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PDS Implant filled with 100 mg/mL Ranibizumab
Intravitreal Injections of 10 mg/mL Ranibizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥50 years, at time of signing Informed Consent Form
  • Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit
  • Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
  • Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
  • Best-corrected visual acuity (BCVA) of 34 letters or better

Exclusion Criteria:

  • Subfoveal fibrosis or subfoveal atrophy in study eye
  • Subretinal hemorrhage that involves the center of the fovea in study eye
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
  • Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
  • Previous intraocular device implantation in study eye
  • Previous laser (any type) used for AMD treatment in study eye
  • Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
  • Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye
  • CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye
  • Uncontrolled blood pressure
  • History of stroke within the last 3 months prior to informed consent
  • Uncontrolled atrial fibrillation within 3 months of informed consent
  • History of myocardial infarction within the last 3 months prior to informed consent
  • History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator
  • Current systemic treatment for a confirmed active systemic infection
  • Chronic use of oral corticosteroids
  • Active cancer within 12 months of randomization
  • Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)

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
  • Jules Stein Eye Institute/ UCLA
  • N CA Retina Vitreous Assoc
  • Retina Consultants, San Diego
  • Retinal Consultants Med Group
  • West Coast Retina Medical Group
  • UCSF; Ophthalmology
  • Orange County Retina Med Group
  • California Retina Consultants
  • Bay Area Retina Associates
  • Southwest Retina Consultants
  • Eye Center of Northern CO
  • Colorado Retina Associates, PC
  • Retina Group of New England
  • National Ophthalmic Research Institute
  • Florida Eye Associates
  • Retina Care Specialists
  • 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
  • Illinois Retina Associates
  • University Retina and Macula Associates, PC
  • Wolfe Eye Clinic
  • Retina Associates
  • Retina Associates of Kentucky
  • Paducah Retinal Center
  • Maine Eye Center
  • The Retina Care Center
  • Johns Hopkins Med; Wilmer Eye Inst
  • Retina Group of Washington
  • Retina Specialists
  • Ophthalmic Consultants of Boston
  • Vitreo-Retinal Associates, PC
  • Associated Retinal Consultants
  • Foundation for Vision Research
  • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
  • Midwest Vision Research Foundation
  • The Retina Institute - Chesterfield
  • Sierra Eye Associates
  • Envision Ocular, LLC
  • Mid Atlantic Retina - Wills Eye Hospital
  • NJ Retina Teaneck Clinic
  • Long Is. Vitreoretinal Consult
  • Retina Vit Surgeons/Central NY
  • Vitreous-Retina-Macula
  • Ophthalmic Consultants of Long Island
  • Char Eye Ear &Throat Assoc
  • Cincinnati Eye Institute
  • The Cleveland Clinic Foundation
  • OSU Eye Physicians & Surgeons
  • Retina Vitreous Center
  • Retina Northwest
  • Palmetto Retina Center
  • Charles Retina Institute
  • Tennessee Retina PC
  • Texas Retina Associates
  • Austin Retina Associates
  • Austin Clinical Research LLC
  • Retina Consultants of Texas
  • Texas Retina Associates
  • Med Center Ophthalmology Assoc
  • Retina Associates of Utah
  • Rocky Mountain Retina
  • Wagner Macula & Retina Center
  • 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 Implant Arm

Intravitreal Arm

Arm Description

Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals

Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.

Outcomes

Primary Outcome Measures

Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters
The primary efficacy endpoint is the change in BCVA score from baseline averaged over Weeks 36 and 40 with BCVA assessed using the ETDRS chart at a starting distance of 4 meters. ETDRS = Early Treatment Diabetic Retinopathy Study. The primary objective is to determine the NI and equivalence between the two treatment groups, as measured by the primary efficacy endpoint with a NI margin of 4.5 letters and equivalence margins of ± 4.5 letters. A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.

Secondary Outcome Measures

Change From Baseline in BCVA Score Averaged Over Week 60 and Week 64
Change From Baseline in BCVA Score Over Time
Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse at the Average Over Week 36 and Week 40
Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time
Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better at the Average Over Week 36 and Week 40
Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Over Time
Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40
Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline Over Time
Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40
Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline Over Time
Change From Baseline in Center Point Thickness (CPT) at Week 36
Change From Baseline in CPT Over Time
Percentage of Participants in the PDS Implant Arm Who Undergo Supplemental Treatment With Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, and Fourth Fixed Refill-Exchange Intervals
Percentage of Participants in the PDS Implant Arm Who Undergo a Supplemental Treatment That Requires Subsequent Additional Supplemental Treatments During the Study
Percentage of Participants With Ocular and Systemic (Non-Ocular) AEs
Percentage of Participants With Adverse Events of Special Interest
Percentage of Participants with Adverse Events of Special Interest
Observed Serum Ranibizumab Concentrations at Specified Timepoints
Estimated PK Parameter Values AUC0-6M
AUC0-6M = Area Under the Concentration-Time Curve From 0 to 6 Months
Estimated PK Parameter Value t1/2 After PDS Implant Insertion
Apparent terminal half-life
Estimated PK Parameter Value Cmin
Cmin = Minimum Serum Concentration
Estimated PK Parameter Value Cmax
Cmax = Maximum Serum Concentration
Baseline Prevalence and Incidence of Treatment-Emergent ADA

Full Information

First Posted
September 11, 2018
Last Updated
September 6, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03677934
Brief Title
A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
Acronym
Archway
Official Title
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 Neovascular Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
May 22, 2020 (Actual)
Study Completion Date
June 9, 2021 (Actual)

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
Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-Related Macular Degeneration

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
PDS Implant Arm
Arm Type
Experimental
Arm Description
Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
Arm Title
Intravitreal Arm
Arm Type
Active Comparator
Arm Description
Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.
Intervention Type
Drug
Intervention Name(s)
PDS Implant 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 Injections of 10 mg/mL Ranibizumab
Intervention Description
Will be administered as per the schedule described in individual arm.
Primary Outcome Measure Information:
Title
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters
Description
The primary efficacy endpoint is the change in BCVA score from baseline averaged over Weeks 36 and 40 with BCVA assessed using the ETDRS chart at a starting distance of 4 meters. ETDRS = Early Treatment Diabetic Retinopathy Study. The primary objective is to determine the NI and equivalence between the two treatment groups, as measured by the primary efficacy endpoint with a NI margin of 4.5 letters and equivalence margins of ± 4.5 letters. A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.
Time Frame
Baseline, and the average of Week 36 and Week 40
Secondary Outcome Measure Information:
Title
Change From Baseline in BCVA Score Averaged Over Week 60 and Week 64
Time Frame
Baseline, Week60, Week 64
Title
Change From Baseline in BCVA Score Over Time
Time Frame
Baseline up to Week 96
Title
Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse at the Average Over Week 36 and Week 40
Time Frame
Baseline, and the average of Week 36 and Week 40
Title
Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time
Time Frame
Baseline up to Week 96
Title
Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better at the Average Over Week 36 and Week 40
Time Frame
Baseline, and the average of Week 36 and Week 40
Title
Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Over Time
Time Frame
Baseline up to Week 96
Title
Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40
Time Frame
Baseline, and the average of Week 36 and Week 40
Title
Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline Over Time
Time Frame
Baseline up to Week 96
Title
Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40
Time Frame
Baseline up to Week 40
Title
Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline Over Time
Time Frame
Baseline up to Week 96
Title
Change From Baseline in Center Point Thickness (CPT) at Week 36
Time Frame
Baseline to Week 36
Title
Change From Baseline in CPT Over Time
Time Frame
Baseline up to Week 96
Title
Percentage of Participants in the PDS Implant Arm Who Undergo Supplemental Treatment With Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, and Fourth Fixed Refill-Exchange Intervals
Time Frame
Day 1 to Week 24, Week 25 to Week 48, Week 49 to Week 72, Week73 to Week 96
Title
Percentage of Participants in the PDS Implant Arm Who Undergo a Supplemental Treatment That Requires Subsequent Additional Supplemental Treatments During the Study
Time Frame
Week 16 to Week 92
Title
Percentage of Participants With Ocular and Systemic (Non-Ocular) AEs
Time Frame
Randomization to Week 96
Title
Percentage of Participants With Adverse Events of Special Interest
Description
Percentage of Participants with Adverse Events of Special Interest
Time Frame
Randomization to Week 96
Title
Observed Serum Ranibizumab Concentrations at Specified Timepoints
Time Frame
Randomization to Week 96
Title
Estimated PK Parameter Values AUC0-6M
Description
AUC0-6M = Area Under the Concentration-Time Curve From 0 to 6 Months
Time Frame
Randomization to Week 96
Title
Estimated PK Parameter Value t1/2 After PDS Implant Insertion
Description
Apparent terminal half-life
Time Frame
Randomization to Week 96
Title
Estimated PK Parameter Value Cmin
Description
Cmin = Minimum Serum Concentration
Time Frame
Randomization to Week 96
Title
Estimated PK Parameter Value Cmax
Description
Cmax = Maximum Serum Concentration
Time Frame
Randomization to Week 96
Title
Baseline Prevalence and Incidence of Treatment-Emergent ADA
Time Frame
Randomization to Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥50 years, at time of signing Informed Consent Form Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis Best-corrected visual acuity (BCVA) of 34 letters or better Exclusion Criteria: Subfoveal fibrosis or subfoveal atrophy in study eye Subretinal hemorrhage that involves the center of the fovea in study eye History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye Previous intraocular device implantation in study eye Previous laser (any type) used for AMD treatment in study eye Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye Uncontrolled blood pressure History of stroke within the last 3 months prior to informed consent Uncontrolled atrial fibrillation within 3 months of informed consent History of myocardial infarction within the last 3 months prior to informed consent History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator Current systemic treatment for a confirmed active systemic infection Chronic use of oral corticosteroids Active cancer within 12 months of randomization Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
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
Jules Stein Eye Institute/ UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7000
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
Retina Consultants, San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Retinal Consultants Med Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
West Coast Retina Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
UCSF; Ophthalmology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
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
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Southwest Retina Consultants
City
Durango
State/Province
Colorado
ZIP/Postal Code
81303
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
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Retina Care Specialists
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
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
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
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
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
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
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
Retina Specialists
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Vitreo-Retinal Associates, PC
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
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
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
City
Edina
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 - Chesterfield
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
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 - Wills Eye Hospital
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
NJ Retina Teaneck Clinic
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Long Is. Vitreoretinal Consult
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
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
Vitreous-Retina-Macula
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
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
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OSU Eye Physicians & Surgeons
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
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
Palmetto Retina Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Charles Retina Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Tennessee Retina PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
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
Country
United States
Facility Name
Austin Clinical Research LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Retina Consultants of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
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 Associates of Utah
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
Wagner Macula & Retina Center
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.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study 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).
Citations:
PubMed Identifier
35708706
Citation
Chang MA, Kapre A, Kaufman D, Kardatzke DR, Rabena M, Patel S, Bobbala A, Gune S, Fung A, Wallenstein G. Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 Aug 1;140(8):771-778. doi: 10.1001/jamaophthalmol.2022.1091.
Results Reference
derived
PubMed Identifier
35589078
Citation
Awh CC, Barteselli G, Makadia S, Chang RT, Stewart JM, Wieland MR, Brassard R, Callaway NF, Gune S, Heatherton P, Malhotra V, Willis JR, Pieramici DJ. Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab. Ophthalmol Retina. 2022 Nov;6(11):1028-1043. doi: 10.1016/j.oret.2022.05.011. Epub 2022 May 16.
Results Reference
derived
PubMed Identifier
33863399
Citation
Heimann F, Barteselli G, Brand A, Dingeldey A, Godard L, Hochstetter H, Schneider M, Rothkegel A, Wagner C, Horvath J, Ranade S. A custom virtual reality training solution for ophthalmologic surgical clinical trials. Adv Simul (Lond). 2021 Apr 16;6(1):12. doi: 10.1186/s41077-021-00167-z.
Results Reference
derived

Learn more about this trial

A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration

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