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

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.

Conditions

Neovascular Age-Related Macular Degeneration

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Neovascular Age-Related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Mesa

Barnet Dulaney Perkins Eye Center, Mesa, Arizona, United States, 85206

Phoenix

Retinal Research Institute, LLC, Phoenix, Arizona, United States, 85014

Phoenix

Arizona Retina and Vitreous Consultants, Phoenix, Arizona, United States, 85016

Phoenix

Associated Retina Consultants, Phoenix, Arizona, United States, 85020

Phoenix

Retinal Consultants of Arizona, Phoenix, Arizona, United States, 85053

Bakersfield

California Retina Consultants., Bakersfield, California, United States, 93309

Beverly Hills

Retina-Vitreous Associates Medical Group, Beverly Hills, California, United States, 90211

Encino

The Retina Partners, Encino, California, United States, 91436

La Jolla

Jacobs Retina center at the Shiley eye Institute UCSD, La Jolla, California, United States, 92037

Los Angeles

Jules Stein Eye Institute/ UCLA, Los Angeles, California, United States, 90095-7000

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * Ability and willingness to undertake all scheduled visits and assessments
  • * For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
  • * 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
  • * 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
  • * 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
  • * Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"
  • * Diagnosis of exudative nAMD within 2 years prior to the enrollment visit
  • * 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
  • * Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following:
  • * 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).
  • * 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.
  • * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • * Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
  • * Previous treatment with corticosteroid ITV injection
  • * Previous intraocular device implantation
  • * Previous laser (any type) used for AMD treatment
  • * Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit
  • * Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab
  • * 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
  • * Subfoveal fibrosis or subfoveal atrophy
  • * Retinal pigment epithelial tear
  • * 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
  • * Active intraocular inflammation (grade trace or above)
  • * History of vitreous hemorrhage
  • * History of rhegmatogenous retinal detachment
  • * History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
  • * Aphakia or absence of the posterior capsule
  • * 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.
  • * Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia
  • * Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye
  • * Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit
  • * 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
  • * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
  • * History of corneal transplant
  • * History of prior vitrectomy surgery and absence of posterior capsule
  • * History of idiopathic or autoimmune-associated uveitis
  • * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
  • * Inability to comply with study schedule or procedures as described in the study protocol
  • * 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 patient at high risk of treatment complications in the opinion of the investigator
  • * Current systemic treatment for a confirmed active systemic infection
  • * Use of any systemic anti-VEGF agents
  • * Chronic use of oral corticosteroids
  • * Active cancer within 12 months of enrollment
  • * Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
  • * Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
  • * History of albinism
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2029-09-30