search
Back to results

Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (LADDER)

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

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

Inclusion Criteria:

  • Newly diagnosed with wet AMD within 9 months of screening visit
  • Participant must have received at least 2 prior ITV anti-vascular endothelial growth factor (VEGF) injections. However, the most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit
  • Demonstrated response to prior ITV anti-VEGF treatment
  • Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/20-20/200 Snellen equivalent

Exclusion Criteria:

  • Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
  • Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit
  • History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD in the study eye
  • Prior participation in a clinical trial involving anti-angiogenic drugs, other than ranibizumab, in either eye within 2 months of the randomization visit
  • Subretinal hemorrhage in the study eye that involves the center of the fovea
  • Subfoveal fibrosis, or atrophy in the study eye
  • Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Uncontrolled ocular hypertension or glaucoma in the study eye
  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye
  • Uncontrolled blood pressure
  • Uncontrolled atrial fibrillation within 3 months of informed consent
  • History of myocardial infarction or stroke within the last 3 months prior to informed consent
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant, that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications
  • Use of oral corticosteroids
  • Current treatment for any active systemic infection
  • Use of anticoagulants, anti-platelets (other than aspirin), or medications known to exert similar effects
  • Active malignancy within 12 months of randomization
  • History of allergy to fluorescein
  • 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
  • Retinal Research Institute, LLC
  • Associated Retina Consultants
  • The Retina Partners
  • Jacobs Retina center at the Shiley eye Institute UCSD
  • Jules Stein Eye Institute/ UCLA
  • N CA Retina Vitreous Assoc
  • Retinal Consultants Med Group
  • West Coast Retina Medical Group
  • UCSF; Ophthalmology
  • Orange County Retina Med Group
  • California Retina Consultants
  • Retina Consultants of Southern
  • Colorado Retina Associates, PC
  • Florida Eye Microsurgical Inst
  • National Ophthalmic Research Institute
  • Retina Specialty Institute
  • Retina Vitreous Assoc of FL
  • Retina Associates of Florida, LLC
  • Southeast Retina Center
  • Illinois Retina Associates
  • Wolfe Eye Clinic
  • Retina Associates of Kentucky
  • Paducah Retinal Center
  • Johns Hopkins Med; Wilmer Eye Inst
  • Retina Group of Washington
  • Retina Specialists
  • Vitreo-Retinal Associates, PC
  • Foundation for Vision Research
  • Vitreoretinal Surgery
  • Sierra Eye Associates
  • Retina Center of New Jersey
  • Mid Atlantic Retina - Wills Eye Hospital
  • Eye Associates of New Mexico
  • University of New Mexico; School of Med
  • Retina Assoc of Western NY
  • Char Eye Ear &Throat Assoc
  • Cincinnati Eye Institute
  • The Cleveland Clinic Foundation
  • Retina Northwest
  • Oregon HSU; Casey Eye Institute
  • Palmetto Retina Center
  • Charles Retina Institute
  • Tennessee Retina PC.
  • Texas Retina Associates
  • Retina Research Center
  • Retina Consultants of Texas
  • Med Center Ophthalmology Assoc
  • Retina Associates of Utah
  • Wagner Macula & Retina Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Port Delivery System with Ranibizumab 10mg/mL

Port Delivery System with Ranibizumab 40mg/mL

Port Delivery System with Ranibizumab 100mg/mL

Intravitreal Injection with Ranibizumab 0.5mg

Arm Description

Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.

Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.

Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.

Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.

Outcomes

Primary Outcome Measures

Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria
Protocol-Defined Refill Criteria At 1 month after initial fill: Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR Presence of new macular hemorrhage, due to nAMD disease activity For subsequent assessments: Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the last 2 available measurements, due to nAMD disease activity OR Increase in CFT of ≥ 100 um from the lowest CFT measurement on study, due to nAMD disease activity OR Decrease of ≥ 5 letters in BCVA at the current visit compared with the average BCVA over the last 2 available measurements, due to nAMD disease activity OR Decrease of ≥ 10 letters from best recorded BCVA on study, due to nAMD disease activity OR Presence of new macular hemorrhage, due to nAMD disease activity

Secondary Outcome Measures

Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
Change From Baseline in BCVA Over Time
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
Adjusted Average Change From Baseline in BCVA Over Time (MMRM Analysis)
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. Here, the adjusted mean from MMRM analysis is presented).
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Central foveal thickness (CFT) is defined as the retinal thickness in the center of the fovea
Number of Implant Clogging at Month 9
Removed implants identified as meeting serum PK criteria for possible clogging were assessed via lab-based investigation (in vitro drug release testing) to determine whether there was any implant clogging.
Observed Maximum Serum Concentration (Cmax) of Ranibizumab
The serum pharmacokinetics of ranibizumab were characterized by estimating Cmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Area Under the Concentration-Time Curve From Dosing to Last Observation (AUClast) of Ranibizumab
AUCLast is defined as area under the concentration-time curve from dosing (implant or refill) to last observation before next refill or exiting the study. The serum pharmacokinetics of ranibizumab were characterized by estimating AUC between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Time to Maximum Concentration (Tmax) of Ranibizumab
The serum pharmacokinetics of ranibizumab were characterized by estimating Tmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Terminal Half-Life (t1/2) of Ranibizumab
The serum pharmacokinetics of ranibizumab were characterized by estimating t1/2 between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Observed Steady-State Serum Concentration at the End of a Dosing Interval (Ctrough) of Ranibizumab
Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)
Percentage of Participants With Positive Serum Antibodies to Ranibizumab

Full Information

First Posted
July 17, 2015
Last Updated
April 12, 2021
Sponsor
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02510794
Brief Title
Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
Acronym
LADDER
Official Title
A Phase II, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2015 (Actual)
Primary Completion Date
April 10, 2018 (Actual)
Study Completion Date
March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
This is a Phase II multicenter, dose-ranging, randomized, active treatment (monthly ITV injection)-controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in participants with subfoveal 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
Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Port Delivery System with Ranibizumab 10mg/mL
Arm Type
Experimental
Arm Description
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
Arm Title
Port Delivery System with Ranibizumab 40mg/mL
Arm Type
Experimental
Arm Description
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
Arm Title
Port Delivery System with Ranibizumab 100mg/mL
Arm Type
Experimental
Arm Description
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
Arm Title
Intravitreal Injection with Ranibizumab 0.5mg
Arm Type
Active Comparator
Arm Description
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Ranibizumab will be administered at dose of 0.5 mg monthly ITV injections of 10-mg/mL formulation or delivered through the implant with three different formulations.
Primary Outcome Measure Information:
Title
Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria
Description
Protocol-Defined Refill Criteria At 1 month after initial fill: Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR Presence of new macular hemorrhage, due to nAMD disease activity For subsequent assessments: Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the last 2 available measurements, due to nAMD disease activity OR Increase in CFT of ≥ 100 um from the lowest CFT measurement on study, due to nAMD disease activity OR Decrease of ≥ 5 letters in BCVA at the current visit compared with the average BCVA over the last 2 available measurements, due to nAMD disease activity OR Decrease of ≥ 10 letters from best recorded BCVA on study, due to nAMD disease activity OR Presence of new macular hemorrhage, due to nAMD disease activity
Time Frame
Baseline up to approximately 38 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10
Description
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
Time Frame
Baseline, Months 9, 10
Title
Change From Baseline in BCVA Over Time
Description
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
Time Frame
Baseline up to Month 10
Title
Adjusted Average Change From Baseline in BCVA Over Time (MMRM Analysis)
Description
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. Here, the adjusted mean from MMRM analysis is presented).
Time Frame
Baseline up to Month 10
Title
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Description
Central foveal thickness (CFT) is defined as the retinal thickness in the center of the fovea
Time Frame
Baseline up to Month 9
Title
Number of Implant Clogging at Month 9
Description
Removed implants identified as meeting serum PK criteria for possible clogging were assessed via lab-based investigation (in vitro drug release testing) to determine whether there was any implant clogging.
Time Frame
Month 9
Title
Observed Maximum Serum Concentration (Cmax) of Ranibizumab
Description
The serum pharmacokinetics of ranibizumab were characterized by estimating Cmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Time Frame
Predose (0 hour) on Day 1 up to 38 months
Title
Area Under the Concentration-Time Curve From Dosing to Last Observation (AUClast) of Ranibizumab
Description
AUCLast is defined as area under the concentration-time curve from dosing (implant or refill) to last observation before next refill or exiting the study. The serum pharmacokinetics of ranibizumab were characterized by estimating AUC between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Time Frame
Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in description field)
Title
Time to Maximum Concentration (Tmax) of Ranibizumab
Description
The serum pharmacokinetics of ranibizumab were characterized by estimating Tmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Time Frame
Predose (0 hour) on Day 1 up to 38 months
Title
Terminal Half-Life (t1/2) of Ranibizumab
Description
The serum pharmacokinetics of ranibizumab were characterized by estimating t1/2 between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Time Frame
Predose (0 hour) on Day 1 up to 38 months
Title
Observed Steady-State Serum Concentration at the End of a Dosing Interval (Ctrough) of Ranibizumab
Time Frame
Predose (0 hour) on Day 1 up to 38 months
Title
Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame
Baseline up to approximately Month 38
Title
Percentage of Participants With Positive Serum Antibodies to Ranibizumab
Time Frame
Baseline up to 38 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed with wet AMD within 9 months of screening visit Participant must have received at least 2 prior ITV anti-vascular endothelial growth factor (VEGF) injections. However, the most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit Demonstrated response to prior ITV anti-VEGF treatment Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/20-20/200 Snellen equivalent Exclusion Criteria: Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD in the study eye Prior participation in a clinical trial involving anti-angiogenic drugs, other than ranibizumab, in either eye within 2 months of the randomization visit Subretinal hemorrhage in the study eye that involves the center of the fovea Subfoveal fibrosis, or atrophy in the study eye Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Uncontrolled ocular hypertension or glaucoma in the study eye History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye Uncontrolled blood pressure Uncontrolled atrial fibrillation within 3 months of informed consent History of myocardial infarction or stroke within the last 3 months prior to informed consent History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant, that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications Use of oral corticosteroids Current treatment for any active systemic infection Use of anticoagulants, anti-platelets (other than aspirin), or medications known to exert similar effects Active malignancy within 12 months of randomization History of allergy to fluorescein 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
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
The Retina Partners
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Jacobs Retina center at the Shiley eye Institute UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
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
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
Retina Consultants of Southern
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Colorado Retina Associates, PC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Florida Eye Microsurgical Inst
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
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
Retina Vitreous Assoc of FL
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
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
Illinois Retina Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
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 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
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
Vitreo-Retinal Associates, PC
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
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
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Retina Center of New Jersey
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
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
University of New Mexico; School of Med
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Retina Assoc of Western NY
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
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
Retina Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Facility Name
Oregon HSU; Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
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
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
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Retina Research Center
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
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
Wagner Macula & Retina Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35759124
Citation
Wykoff CC, Campochiaro PA, Pieramici DJ, Khanani AM, Gune S, Maia M, Kagedal M, Ding HT, Maass KF. Pharmacokinetics of the Port Delivery System with Ranibizumab in the Ladder Phase 2 Trial for Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2022 Oct;11(5):1705-1717. doi: 10.1007/s40123-022-00532-9. Epub 2022 Jun 27.
Results Reference
derived
PubMed Identifier
35248647
Citation
Yohe S, Maass KF, Horvath J, Rea J, Barteselli G, Ranade SV. In-vitro characterization of ranibizumab release from the Port Delivery System. J Control Release. 2022 May;345:101-107. doi: 10.1016/j.jconrel.2022.03.005. Epub 2022 Mar 4.
Results Reference
derived

Learn more about this trial

Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration

We'll reach out to this number within 24 hrs