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NCT04853251PHASE4Recruiting

A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

Genentech, Inc.

Start Date

12/14/2021

Completion Date

10/29/2027

Summary

This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).

Eligibility Criteria

Age Range: 50 years to No maximum

Inclusion Criteria Ocular Inclusion Criteria: * Diagnosis of nAMD prior to screening as determined by the investigator * 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 Prior Ocular Treatment 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

Interventions

DEVICE

PDS Implant With Ranibizumab 100 mg/ml

DRUG

LUCENTIS (Ranibizumab Injection)

Interested in This Trial?

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Conditions

Neovascular Age-related Macular Degeneration

Locations

Barnet Dulaney Perkins Eye Center

Mesa, Arizona 85206-2747

United States

California Retina Consultants

Bakersfield, California 93309

United States

Retina Associates of Southern California

Huntington Beach, California 92647

United States

California Eye Specialists Medical group Inc.

Pasadena, California 91107-3747

United States

Retinal Consultants Med Group

Sacramento, California 95841-2013

United States

University of California San Francisco

San Francisco, California 94158-2510

United States

Orange County Retina Med Group

Santa Ana, California 92705-6504

United States

Macula Retina Vitreous Research Institute

Torrance, California 90503-3270

United States

Southwest Retina Consultants

Durango, Colorado 81303

United States

Advanced Vision Research Institute

Longmont, Colorado 80503-6499

United States

Retina Group of New England

Waterford, Connecticut 06385-1215

United States

Retina Specialty Institute

Pensacola, Florida 32503-2030

United States

Ft Lauderdale Eye Institute

Plantation, Florida 33324-3118

United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida 33711-1141

United States

Southeast Retina Center

Augusta, Georgia 30909-6440

United States

University Retina and Macula Associates, PC

Lemont, Illinois 60439-7421

United States

Wolfe Eye Clinic

West Des Moines, Iowa 50266

United States

Retina Associates of Kentucky

Lexington, Kentucky 40509-1827

United States

Maine Eye Center

Portland, Maine 04101

United States

The Retina Care Center

Baltimore, Maryland 21209-2219

United States

Wilmer Eye Institute Johns Hopkins University

Baltimore, Maryland 21287-0005

United States

Retina Group of Washington

Chevy Chase, Maryland 20815-6956

United States

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland 21740

United States

Associated Retinal Consultants PC

Royal Oak, Michigan 48073

United States

VitreoRetinal Surgery, PLLC.

Minneapolis, Minnesota 55435-3004

United States

Midwest Vision Research Foundation

Chesterfield, Missouri 63017-5065

United States

Sierra Eye Associates

Reno, Nevada 89502-1605

United States

Envision Ocular, LLC

Bloomfield, New Jersey 07003

United States

Seeta Eye Centers

Poughkeepsie, New York 12603-2416

United States

Western Carolina Retinal Associate PA

Asheville, North Carolina 28803-2493

United States

Duke Eye Center

Durham, North Carolina 27705-4699

United States

Graystone Eye

Hickory, North Carolina 28602

United States

Fargo Retina Consultants

Fargo, North Dakota 58047

United States

Cincinnati Eye Institute

Blue Ash, Ohio 45242-5537

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Tulsa Retina Consultants

Tulsa, Oklahoma 74114

United States

Erie Retina Research

Erie, Pennsylvania 16505

United States

Mid Atlantic Retina

Philadelphia, Pennsylvania 19107-5109

United States

Palmetto Retina Center

Florence, South Carolina 29501

United States

Palmetto Retina Center, LLC

West Columbia, South Carolina 29169-2429

United States

Charles Retina Institute

Germantown, Tennessee 38138-2405

United States

Tennessee Retina PC

Nashville, Tennessee 37203-1596

United States

Panhandle Eye Group LLP Southwest Retina Specialists

Amarillo, Texas 79106-1835

United States

Austin Retina Associates

Austin, Texas 78705-1169

United States

Austin Clinical Research, LLC

Austin, Texas 78750-2298

United States

Retina Consultants of Texas

Bellaire, Texas 77401

United States

Retina Consultants of Texas

Schertz, Texas 78154

United States

Retina Associates of Utah, PLLC

Salt Lake City, Utah 84107-6767

United States

Piedmont Eye Center

Lynchburg, Virginia 24502-4271

United States

Wagner Kapoor Institute

Norfolk, Virginia 23502-3933

United States

Retina Institute of Virginia

Richmond, Virginia 23235-1962

United States

Spokane Eye Clinical Research

Spokane, Washington 99204

United States