RECRUITING

Extension Study for the Port Delivery System With Ranibizumab (Portal)

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Conditions

Neovascular Age-Related Macular Degeneration

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.

Official Title

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)

Quick Facts

Study Start:2018-09-20
Study Completion:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03683251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
  2. * Ability and willingness to undertake all scheduled visits and assessments
  3. * For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
  1. * Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab
  2. * History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications
  3. * History of other diseases, 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 that renders the participant at high risk of treatment complications
  4. * Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"
  5. * Diagnosis of exudative nAMD within 2 years prior to the enrollment visit
  6. * Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit
  7. * Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following:
  8. * All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea).
  9. * Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP and SD-OCT images.
  10. * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  11. * Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
  12. * Previous treatment with corticosteroid ITV injection
  13. * Previous intraocular device implantation
  14. * Previous laser (any type) used for AMD treatment
  15. * Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit
  16. * Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab
  17. * Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening
  18. * Subfoveal fibrosis or subfoveal atrophy
  19. * Retinal pigment epithelial tear
  20. * Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results
  21. * Active intraocular inflammation (grade trace or above)
  22. * History of vitreous hemorrhage
  23. * History of rhegmatogenous retinal detachment
  24. * History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
  25. * Aphakia or absence of the posterior capsule
  26. * Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
  27. * Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia
  28. * Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye
  29. * Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit
  30. * 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
  31. * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
  32. * History of corneal transplant
  33. * History of prior vitrectomy surgery and absence of posterior capsule
  34. * History of idiopathic or autoimmune-associated uveitis
  35. * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
  36. * Inability to comply with study schedule or procedures as described in the study protocol
  37. * Uncontrolled blood pressure
  38. * History of stroke within the last 3 months prior to informed consent
  39. * Uncontrolled atrial fibrillation within 3 months of informed consent
  40. * History of myocardial infarction within the last 3 months prior to informed consent
  41. * 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 patient at high risk of treatment complications in the opinion of the investigator
  42. * Current systemic treatment for a confirmed active systemic infection
  43. * Use of any systemic anti-VEGF agents
  44. * Chronic use of oral corticosteroids
  45. * Active cancer within 12 months of enrollment
  46. * Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
  47. * Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
  48. * History of albinism
  49. * Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab

Contacts and Locations

Study Contact

Reference Study ID Number: GR40549 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85206
United States
Retinal Research Institute, LLC
Phoenix, Arizona, 85014
United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85016
United States
Associated Retina Consultants
Phoenix, Arizona, 85020
United States
Retinal Consultants of Arizona
Phoenix, Arizona, 85053
United States
California Retina Consultants.
Bakersfield, California, 93309
United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
United States
The Retina Partners
Encino, California, 91436
United States
Jacobs Retina center at the Shiley eye Institute UCSD
La Jolla, California, 92037
United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California, 90095-7000
United States
N CA Retina Vitreous Assoc
Mountain View, California, 94040
United States
Retina Consultants, San Diego
Poway, California, 92064
United States
Retinal Consultants Med Group
Sacramento, California, 95825
United States
West Coast Retina Medical Group
San Francisco, California, 94109
United States
UCSF; Ophthalmology
San Francisco, California, 94143
United States
Orange County Retina Med Group
Santa Ana, California, 92705
United States
California Retina Consultants
Santa Barbara, California, 93103
United States
Southwest Retina Consultants
Durango, Colorado, 81303
United States
Eye Center of Northern CO
Fort Collins, Colorado, 80528
United States
Colorado Retina Associates, PC
Lakewood, Colorado, 80228
United States
Retina Group of New England
Waterford, Connecticut, 06385
United States
Florida Eye Microsurgical Inst
Boynton Beach, Florida, 33426
United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
United States
Florida Eye Associates
Melbourne, Florida, 32901
United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410
United States
Retina Specialty Institute
Pensacola, Florida, 32503
United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324
United States
Retina Vitreous Assoc of FL
Saint Petersburg, Florida, 33711
United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, 32308
United States
Retina Associates of Florida, LLC
Tampa, Florida, 33609
United States
Southeast Retina Center
Augusta, Georgia, 30909
United States
Georgia Retina PC
Marietta, Georgia, 30060-1137
United States
Illinois Retina Associates
Joliet, Illinois, 60435
United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452
United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
United States
Retina Associates
Lenexa, Kansas, 66215
United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509
United States
Paducah Retinal Center
Paducah, Kentucky, 42001
United States
Maine Eye Center
Portland, Maine, 04101
United States
The Retina Care Center
Baltimore, Maryland, 21209
United States
Johns Hopkins Med; Wilmer Eye Inst
Baltimore, Maryland, 21287
United States
Retina Group of Washington
Chevy Chase, Maryland, 20815
United States
Retina Specialists
Towson, Maryland, 21204
United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
United States
Associated Retinal Consultants
Grand Rapids, Michigan, 49546
United States
Foundation for Vision Research
Grand Rapids, Michigan, 49546
United States
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
Edina, Minnesota, 55435
United States
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017
United States
The Retina Institute - Chesterfield
Chesterfield, Missouri, 63017
United States
Sierra Eye Associates
Reno, Nevada, 89502
United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
United States
Retina Associates of NJ
Teaneck, New Jersey, 07666
United States
University of New Mexico; School of Med
Albuquerque, New Mexico, 87131
United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, 11788
United States
Retina Vit Surgeons/Central NY
Liverpool, New York, 13088
United States
Ophthalmic Consultants of Long Island
Oceanside, New York, 11572
United States
Retina Assoc of Western NY
Rochester, New York, 14620
United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, 28210
United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
OSU Eye Physicians & Surgeons
Columbus, Ohio, 43212
United States
Retina Vitreous Center
Edmond, Oklahoma, 73013
United States
Retina Northwest
Portland, Oregon, 97221
United States
Oregon HSU; Casey Eye Institute
Portland, Oregon, 97239
United States
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
United States
Palmetto Retina Center, LLC
West Columbia, South Carolina, 29169
United States
Palmetto Retina Center
West Columbia, South Carolina, 29169
United States
Charles Retina Institute
Germantown, Tennessee, 38138
United States
Tennessee Retina PC
Nashville, Tennessee, 37203
United States
Texas Retina Associates
Arlington, Texas, 76012
United States
Austin Retina Associates
Austin, Texas, 78705-1169
United States
Austin Clinical Research LLC
Austin, Texas, 78750
United States
Texas Retina Associates
Fort Worth, Texas, 76104
United States
Med Center Ophthalmology Assoc
San Antonio, Texas, 78240
United States
Retina Consultants of Texas
The Woodlands, Texas, 77384-4167
United States
Retina Associates of Utah, PLLC
Salt Lake City, Utah, 84107
United States
Rocky Mountain Retina
Salt Lake City, Utah, 84107
United States
Wagner Kapoor Institute
Norfolk, Virginia, 23502
United States
Pacific Northwest Retina
Silverdale, Washington, 98383
United States
Spokane Eye Clinical Research
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-20
Study Completion Date2029-09-30

Study Record Updates

Study Start Date2018-09-20
Study Completion Date2029-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Neovascular Age-Related Macular Degeneration