Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677934
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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 (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: PDS Implant filled with 100 mg/mL Ranibizumab Drug: Intravitreal Injections of 10 mg/mL Ranibizumab Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : May 26, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: PDS Implant Arm
Participants will receive ranibizumab delivered through the implant with 100 mg/mL in the study eye on Day 1 and receive refills at fixed 24-week intervals
Drug: PDS Implant filled with 100 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.

Active Comparator: Intravitreal Arm
Participants will receive ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
Drug: Intravitreal Injections of 10 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.




Primary Outcome Measures :
  1. Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the EDTRS Visual Acuity Chart at a Starting Distance of 4 Meters [ Time Frame: Baseline to Week 40 ]

    EDTRS = 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 :
  1. Percentage of Participants Who Lose <15 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40 [ Time Frame: Baseline to Week 40 ]
  2. Percentage of Participants Who Lose <15 Letters in BCVA From Baseline Over Time [ Time Frame: Baseline up to Week 96 ]
  3. Change from Baseline in BCVA Score Averaged Over Week 60 and Week 64 [ Time Frame: Baseline to Week 64 ]
  4. Change From Baseline in BCVA Score Over Time [ Time Frame: Baseline up to Week 96 ]
  5. Percentage of Participants With BCVA Score of 34 Letters (20/200 Approximate Snellen Equivalent) or Worse at the Average Over Week 36 and Week 40 [ Time Frame: Baseline to Week 40 ]
  6. Percentage of participants With BCVA Score of 34 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time [ Time Frame: Baseline up to Week 96 ]
  7. 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 to Week 40 ]
  8. 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 ]
  9. Percentage of Participants who Lose <10, <5, or <0 Letters in BCVA score from Baseline to the Average Over Week 36 and Week 40 [ Time Frame: Baseline to Week 40 ]
  10. Percentage of Participants who Lose <10, <5, or <0 Letters in BCVA Score From Baseline Over Time [ Time Frame: Baseline up to Week 96 ]
  11. Change From Baseline in Center Point Thickness (CPT) at Week 36 [ Time Frame: Baseline to Week 36 ]
  12. Change From Baseline in CPT Over Time [ Time Frame: Baseline up to Week 96 ]
  13. Percentage of Participants in the Implant Arm Who Undergo Rescue Treatment of Intravitreal Ranibizumab Before the First, Second, Third, and Fourth Fixed Refill Intervals [ Time Frame: Week 16 to Week 92 ]
  14. Percentage of Participants in the Implant Arm That Undergo a Rescue Treatment That Requires Subsequent Additional Rescue Treatments During the Study [ Time Frame: Week 16 to Week 92 ]
  15. Incidence and Severity of Ocular and Systemic (Non-Ocular) AEs [ Time Frame: Randomization to Week 96 ]
    AEs = Adverse Events

  16. Incidence, Severity, and Duration of AESIs, Including PDS-Associated AEs [ Time Frame: Randomization to Week 96 ]
    AESIs = Adverse Events of Special Interest

  17. Incidence, Severity, and Duration of PDS-Associated Ocular AEs During the Postoperative Period (up to 4 Weeks of Initial Implantation) and Follow-Up Period (>4 Weeks After Implantation Surgery) [ Time Frame: Randomization to Week 96 ]
  18. Observed Serum Ranibizumab Concentrations at Specified Timepoints [ Time Frame: Randomization to Week 96 ]
  19. Estimated PK Parameter Values AUC0-6M [ Time Frame: Randomization to Week 96 ]
    AUC0-6M = Area Under the Concentration-Time Curve From 0 to 6 Months

  20. Estimated PK Parameter Value t1/2 After PDS Implant Insertion [ Time Frame: Randomization to Week 96 ]
    t1/2 = Half-Life

  21. Estimated PK Parameter Value Cmin [ Time Frame: Randomization to Week 96 ]
    Cmin = Minimum Serum Concentration

  22. Estimated PK Parameter Value Cmax [ Time Frame: Randomization to Week 96 ]
    Cmax = Maximum Serum Concentration

  23. Participants who Were ADA Negative at Baseline and Became Positive Only After Dosing [ Time Frame: Randomization to Week 96 ]
    ADA = Anti-Drug Antibody

  24. Participants who Were ADA Positive at Randomization and ADA Titer Increased After Dosing [ Time Frame: Randomization to Week 96 ]
  25. Participants who Were ADA Positive at Randomization and ADA Titer did not Increase After Dosing [ Time Frame: Randomization to Week 96 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677934


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: GR40548 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Retinal Consultants of Arizona Recruiting
Phoenix, Arizona, United States, 85012
Associated Retina Consultants Recruiting
Phoenix, Arizona, United States, 85020
Arizona Retina and Vitreous Consultants Recruiting
Phoenix, Arizona, United States, 85021
Barnet Dulaney Perkins Eye Center Recruiting
Sun City, Arizona, United States, 85351
United States, California
California Retina Consultants Active, not recruiting
Bakersfield, California, United States, 93309
Retina-Vitreous Associates Medical Group Active, not recruiting
Beverly Hills, California, United States, 90211
The Retina Partners Recruiting
Encino, California, United States, 91436
Retina Consultants of Orange County Terminated
Fullerton, California, United States, 92835
Jacobs Retina center at the Shiley eye Institute UCSD Active, not recruiting
La Jolla, California, United States, 92037
Jules Stein Eye Institute/ UCLA Recruiting
Los Angeles, California, United States, 90095-7000
N CA Retina Vitreous Assoc Active, not recruiting
Mountain View, California, United States, 94040
Byers Eye Insitute at Stanford Withdrawn
Palo Alto, California, United States, 94303
Retina Consultants, San Diego Recruiting
Poway, California, United States, 92064
Retina Consultants of Southern California Terminated
Redlands, California, United States, 92373
Retinal Consultants Med Group Recruiting
Sacramento, California, United States, 95841
West Coast Retina Medical Group Recruiting
San Francisco, California, United States, 94109
UCSF; Ophthalmology Recruiting
San Francisco, California, United States, 94143
Orange County Retina Med Group Recruiting
Santa Ana, California, United States, 92705
California Retina Consultants Recruiting
Santa Barbara, California, United States, 93103
Bay Area Retina Associates Active, not recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
Southwest Retina Consultants Recruiting
Durango, Colorado, United States, 81301
Eye Center of Northern CO Recruiting
Fort Collins, Colorado, United States, 80528
Colorado Retina Associates, PC Recruiting
Golden, Colorado, United States, 80401
United States, Connecticut
Retina Group of New England Active, not recruiting
Waterford, Connecticut, United States, 06385
United States, Florida
Retina Health Center Withdrawn
Fort Myers, Florida, United States, 33907
National Ophthalmic Research Institute Recruiting
Fort Myers, Florida, United States, 33912
Florida Eye Associates Recruiting
Melbourne, Florida, United States, 32901
Retina Care Specialists Recruiting
Palm Beach Gardens, Florida, United States, 33410
Retina Specialty Institute Recruiting
Pensacola, Florida, United States, 32503
Fort Lauderdale Eye Institute Recruiting
Plantation, Florida, United States, 33324
Retina Vitreous Assoc of FL Recruiting
Saint Petersburg, Florida, United States, 33711
Southern Vitreoretinal Assoc Recruiting
Tallahassee, Florida, United States, 32308
Retina Associates of Florida, LLC Recruiting
Tampa, Florida, United States, 33609
United States, Georgia
Southeast Retina Center Recruiting
Augusta, Georgia, United States, 30909
Georgia Retina PC Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
University of Illinois at Chicago College of Medicine; Illilnois Eye and Ear Infirmary Terminated
Chicago, Illinois, United States, 60612
Illinois Retina Associates Recruiting
Joliet, Illinois, United States, 60435
University Retina and Macula Associates, PC Recruiting
Oak Forest, Illinois, United States, 60452
United States, Iowa
Wolfe Eye Clinic Active, not recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
Retina Associates Recruiting
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Retina Associates of Kentucky Recruiting
Lexington, Kentucky, United States, 40509
Paducah Retinal Center Recruiting
Paducah, Kentucky, United States, 42001
United States, Maine
Maine Eye Center Recruiting
Portland, Maine, United States, 04101
United States, Maryland
The Retina Care Center Active, not recruiting
Baltimore, Maryland, United States, 21209
Johns Hopkins Med; Wilmer Eye Inst Active, not recruiting
Baltimore, Maryland, United States, 21287
Retina Group of Washington Active, not recruiting
Chevy Chase, Maryland, United States, 20815
Retina Specialists Active, not recruiting
Towson, Maryland, United States, 21204
United States, Massachusetts
Tufts Medical Center Terminated
Boston, Massachusetts, United States, 02111
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
Vitreo-Retinal Associates, PC Recruiting
Worcester, Massachusetts, United States, 01605
United States, Michigan
Associated Retinal Consultants Active, not recruiting
Grand Rapids, Michigan, United States, 49546
Foundation for Vision Research Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
Vitreoretinal Surgery Recruiting
Edina, Minnesota, United States, 55435
University of Minnesota Withdrawn
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Midwest Vision Research Foundation Recruiting
Chesterfield, Missouri, United States, 63017
The Retina Institute - Chesterfield Recruiting
Chesterfield, Missouri, United States, 63017
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, New Jersey
Retina Center of New Jersey Recruiting
Bloomfield, New Jersey, United States, 07003
Mid Atlantic Retina - Wills Eye Hospital Active, not recruiting
Cherry Hill, New Jersey, United States, 08034
Retina Associates of NJ Active, not recruiting
Teaneck, New Jersey, United States, 07666
United States, New Mexico
University of New Mexico; School of Med Terminated
Albuquerque, New Mexico, United States, 87131
United States, New York
Long Is. Vitreoretinal Consult Recruiting
Hauppauge, New York, United States, 11788
Vitreous-Retina-Macula Active, not recruiting
New York, New York, United States, 10022
Ophthalmic Consultants of Long Island Recruiting
Rockville Centre, New York, United States, 11570
The Retina Consultants Terminated
Slingerlands, New York, United States, 12159
Retina Vit Surgeons/Central NY Recruiting
Syracuse, New York, United States, 13224
United States, North Carolina
Char Eye Ear &Throat Assoc Recruiting
Charlotte, North Carolina, United States, 28210
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
OSU Eye Physicians & Surgeons Active, not recruiting
Columbus, Ohio, United States, 43212
United States, Oklahoma
Retina Vitreous Center Recruiting
Edmond, Oklahoma, United States, 73013
United States, Oregon
Retina Northwest Recruiting
Portland, Oregon, United States, 97221
Oregon HSU; Casey Eye Institute Terminated
Portland, Oregon, United States, 97239
United States, South Carolina
Palmetto Retina Center Active, not recruiting
Florence, South Carolina, United States, 29501
Palmetto Retina Center Recruiting
Florence, South Carolina, United States, 29501
United States, Tennessee
Charles Retina Institution Recruiting
Germantown, Tennessee, United States, 38138
Tennessee Retina PC Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Retina Associates Recruiting
Arlington, Texas, United States, 76012
Austin Retina Associates Recruiting
Austin, Texas, United States, 78705
Retina Research Center Recruiting
Austin, Texas, United States, 78705
Texas Retina Associates Active, not recruiting
Fort Worth, Texas, United States, 76104
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Valley Retina Institute P.A. Terminated
McAllen, Texas, United States, 78503
Med Center Ophthalmology Assoc Recruiting
San Antonio, Texas, United States, 78240
Retina Consultants of Houston Recruiting
The Woodlands, Texas, United States, 77384
United States, Utah
Retina Associates of Utah Recruiting
Salt Lake City, Utah, United States, 84107
Rocky Mountain Retina Active, not recruiting
Salt Lake City, Utah, United States, 84107
United States, Virginia
Wagner Macula & Retina Center Recruiting
Norfolk, Virginia, United States, 23451
Retina Institute of Virginia Recruiting
Richmond, Virginia, United States, 23235
United States, Washington
Retina Center Northwest Recruiting
Silverdale, Washington, United States, 98383
Spokane Eye Clinical Research Recruiting
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03677934     History of Changes
Other Study ID Numbers: GR40548
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents