A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
NCT ID: NCT04853251
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
188 participants
INTERVENTIONAL
2021-12-14
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SUSVIMO
Participants will have the PDS implant (filled prior to implantation with approximately 20 microlitres \[uL\] of the 100 milligrams/millilitres \[mg/ml\] formulation of ranibizumab \[approximately 2 milligrams (mg) dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals.
PDS Implant With Ranibizumab 100 mg/ml
Ranibizumab 100 mg/mL will be delivered via PDS
LUCENTIS (Ranibizumab Injection)
Ranibizumab (0.5 mg intravitreal \[IVT\] injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a participant discontinues study treatment, he/she may start receiving IVT ranibizumab injections in the study eye, per investigator's discretion.
Interventions
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PDS Implant With Ranibizumab 100 mg/ml
Ranibizumab 100 mg/mL will be delivered via PDS
LUCENTIS (Ranibizumab Injection)
Ranibizumab (0.5 mg intravitreal \[IVT\] injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a participant discontinues study treatment, he/she may start receiving IVT ranibizumab injections in the study eye, per investigator's discretion.
Eligibility Criteria
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Inclusion Criteria
* Difference of \<10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center
* Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion
* Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening
* Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:
* Overall decrease in nAMD disease activity detected on historical or screening OCT
* Stable or improved best-corrected visual acuity (BCVA)
* BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment
* All subtypes of nAMD lesions are permissible
* nAMD lesions at the time of diagnosis must involve the macula
* Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images
Exclusion Criteria
Study Eye:
* Prior treatment with external-beam radiation therapy or transpupillary thermotherapy
* Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening
* Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment
* History of corneal transplant
* History of conjunctival surgery in the superotemporal quadrant
* History of intraocular inflammation following anti-VEGF injection
Either Eye:
* Previous PDS implantation
* Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment
* Prior vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
* Prior pars plana vitrectomy surgery
* Previous intraocular device implantation, excluding intraocular lenses
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
* Prior participation in a clinical trial involving any intravitreal agents that are not approved at time of screening
* Intraocular laser therapy, including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
* Contact lens wear in either eye within 2 months of screening
* Any prior penetrating ocular trauma
* Any prior ocular blunt trauma affecting corneal or retinal health in the opinion of the investigator, or any ocular blunt trauma within 6 months of screening
* History of corneal transplantation, including partial-thickness corneal grafts
* Prior treatment with brolucizumab
* Prior treatment with external-beam radiation therapy or brachytherapy
* History of hypersensitivity to ranibizumab or any excipients of Susvimo
Macular Neovascularization Lesion (MNV) Characteristics
Study Eye:
* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area \[1.27 square millimeters (mm\^2)\] in size
* Subfoveal fibrosis or subfoveal atrophy
Either Eye:
* MNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
* MNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy)
Current or Historical Ocular Conditions
Study Eye:
* Retinal pigment epithelial tear
* Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment
* Current vitreous hemorrhage
* Current or history of retinal detachment
* Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of 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 or evidence of pathologic myopia on depressed fundus examination
* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery
* Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia
* Preoperative refractive error that exceeds 5 diopters of hyperopia, for participants who have undergone prior refractive or cataract surgery
* 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
* Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification)
* Conjunctival pathologies in the superotemporal quadrant
* History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
* Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure
* Trichiasis
* Corneal neuropathy
* Lagophthalmos or incomplete blink
* Active or history of facial nerve palsy/paresis
Fellow (Non-Study) Eye:
• Concurrent or history of PDS implantation
Either Eye:
* Aphakia or absence of the posterior capsule
* Any concurrent intraocular condition 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
* Corneal ECD ≤1500 cells/mm2 in either eye at screening as determined by the independent reading center
* Fuchs endothelial corneal dystrophy Grade ≥ 2
* Previous corneal endothelial cell damage, including from blunt or surgical trauma
* Any ocular condition that precludes obtaining an analyzable specular microscopy image
* Active or history of corneal edema
* Active or history of corneal dystrophies
* Active or history of iridocorneal endothelial syndrome
* Active or history of pseudoexfoliation syndrome
* Active or history of herpetic keratitis or kerato-uveitis
* Any active or history of uveitis
* Active intraocular inflammation
* Active or history of keratitis, scleritis, or endophthalmitis
* Active ocular or periocular infection
* Active or history of Sjogren's syndrome or keratoconjunctivitis sicca
* Active or history of floppy eyelid syndrome
* Active or history of chronic eye rubbing
* Active thyroid eye disease
Concurrent Systemic Conditions:
* History of uncontrolled blood pressure
* Active or history of autoimmune diseases such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegener's)
* History of stroke within the last 3 months prior to screening
* Uncontrolled atrial fibrillation within 3 months of screening
* History of myocardial infarction within the last 3 months prior to screening
* 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 active systemic infection
* Use of any systemic anti-VEGF agents
* Chronic use of oral corticosteroids
* Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 and a stable prostate-specific antigen for \> 12 months
* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals)
* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit
* Requirement for continuous use of any medications or treatments indicated as prohibited therapy
* Pregnant or breastfeeding, or intention to become pregnant during the study
* Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test
50 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
California Retina Consultants
Bakersfield, California, United States
Retina Associates of Southern California
Huntington Beach, California, United States
California Eye Specialists Medical group Inc.
Pasadena, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Orange County Retina Med Group
Santa Ana, California, United States
Macula Retina Vitreous Research Institute
Torrance, California, United States
Southwest Retina Consultants
Durango, Colorado, United States
Advanced Vision Research Institute
Longmont, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Retina Specialty Institute
Pensacola, Florida, United States
Ft Lauderdale Eye Institute
Plantation, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
University Retina and Macula Associates, PC
Lemont, Illinois, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
Maine Eye Center
Portland, Maine, United States
The Retina Care Center
Baltimore, Maryland, United States
Wilmer Eye Institute Johns Hopkins University
Baltimore, Maryland, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants PC
Hagerstown, Maryland, United States
Associated Retinal Consultants PC
Royal Oak, Michigan, United States
VitreoRetinal Surgery, PLLC.
Minneapolis, Minnesota, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Seeta Eye Centers
Poughkeepsie, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Duke Eye Center
Durham, North Carolina, United States
Fargo Retina Consultants
Fargo, North Dakota, United States
Cincinnati Eye Institute
Blue Ash, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Tulsa Retina Consultants
Tulsa, Oklahoma, United States
Erie Retina Research
Erie, Pennsylvania, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Palmetto Retina Center
Florence, South Carolina, United States
Palmetto Retina Center, LLC
West Columbia, South Carolina, United States
Charles Retina Institute
Germantown, Tennessee, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Panhandle Eye Group LLP Southwest Retina Specialists
Amarillo, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Consultants of Texas
Schertz, Texas, United States
Retina Associates of Utah, PLLC
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Kapoor Institute
Norfolk, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Countries
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Central Contacts
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Reference Study ID Number: ML43000 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S.)
Email: [email protected]
Other Identifiers
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ML43000
Identifier Type: -
Identifier Source: org_study_id