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New treatment option for Neovascular Age-Related Macular Degeneration
Official title Extension Study for the Port Delivery System With Ranibizumab (Portal)
ClinicalTrials.gov ID: NCT03683251
What this study is testing
What is PDS Implant with Ranibizumab 100 mg/mL?
PDS Implant with Ranibizumab 100 mg/mL is an investigational medicine, being studied as a potential treatment for neovascular age-related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in...
- Ability and willingness to undertake all scheduled visits and assessments
- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
You likely can't join if
- Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection...
- History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might...
- History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that...
- Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy" Sub-study 1 Inclusion Criteria \- For women of...
- 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...
See the full eligibility criteria
Who can join
- 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...
- Ability and willingness to undertake all scheduled visits and assessments
- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
What rules you out
- 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...
- 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...
- 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...
- Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy" Sub-study 1 Inclusion Criteria \- For women of childbearing potential: agreement to remain abstinent (refrain from...
- 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: Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected...
- 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...
- 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. Exclusion Criteria Prior Ocular Treatments Study Eye
- 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 Either Eye
- 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 CNV Lesion Charateristics Study Eye
- 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 Either Eye \- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Concurrent Ocular Conditions Study Eye
- 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...
- 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...
- 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 Either Eye
- History of idiopathic or autoimmune-associated uveitis
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis Concurrent Systemic Conditions
- 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...
- 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...
- Having experienced septum dislodgement in the original implant while in the main study or after exiting the main study Ocular Inclusion Criteria for Study Eye
- Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center Exclusion Criteria (Cohort 1 only): Concurrent Ocular Conditions-Study Eye
- Any ocular condition that may render the patient at high risk for surgical or treatment complications
- Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
- Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
- History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
- Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
- Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant
- Ongoing ocular complications that might affect participant safety Concurrent Ocular Conditions-Either Eye
- Suspected or active ocular or periocular infection
- Any history of uveitis
- Active blepharitis Concurrent Systemic Conditions
- Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a...
- Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
- Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment...
- Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Encino, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Mountain View, California, United States
- Poway, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Ana, California, United States
- Santa Barbara, California, United States
- Durango, Colorado, United States
- Fort Collins, Colorado, United States
- Lakewood, Colorado, United States
- Waterford, Connecticut, United States
- Boynton Beach, Florida, United States
- Fort Myers, Florida, United States
- Melbourne, Florida, United States
- Palm Beach Gardens, Florida, United States
+ 122 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Bakersfield, California, United States; Beverly Hills, California, United States; Encino, California, United States; La Jolla, California, United States; Los Angeles, California, United States and 136 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.