New eye implant for wet AMD under safety spotlight

NCT ID NCT04853251

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 6 times

Summary

This study is testing a refillable eye implant that delivers the drug ranibizumab to treat wet age-related macular degeneration (AMD). The main goal is to see if the implant affects the cells on the inner surface of the cornea. About 188 people with wet AMD will receive the implant and be followed for 48 weeks. The results will help determine if this device is safe for long-term use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ranibizumab
What this could lead to: If successful, this could confirm that the port delivery system is safe for the cornea, supporting its continued use as a convenient treatment option for wet AMD.
What could go wrong: This is a safety-focused study, not designed to prove the treatment works better. It is still recruiting, and results may show some corneal cell changes that could limit use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 188 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neovascular age-related macular degeneration

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Advanced Vision Research Institute
ACTIVE_NOT_RECRUITING

Longmont, Colorado, 80503-6499, United States
Associated Retinal Consultants PC
ACTIVE_NOT_RECRUITING

Royal Oak, Michigan, 48073, United States
Austin Clinical Research, LLC
RECRUITING

Austin, Texas, 78750-2298, United States
Austin Retina Associates
WITHDRAWN

Austin, Texas, 78705-1169, United States
Barnet Dulaney Perkins Eye Center
ACTIVE_NOT_RECRUITING

Mesa, Arizona, 85206-2747, United States
California Eye Specialists Medical group Inc.
COMPLETED

Pasadena, California, 91107-3747, United States
California Retina Consultants
COMPLETED

Bakersfield, California, 93309, United States
Charles Retina Institute
ACTIVE_NOT_RECRUITING

Germantown, Tennessee, 38138-2405, United States
Cincinnati Eye Institute
ACTIVE_NOT_RECRUITING

Blue Ash, Ohio, 45242-5537, United States
Cleveland Clinic
ACTIVE_NOT_RECRUITING

Cleveland, Ohio, 44195, United States
Cumberland Valley Retina Consultants PC
COMPLETED

Hagerstown, Maryland, 21740, United States
Duke Eye Center
ACTIVE_NOT_RECRUITING

Durham, North Carolina, 27705-4699, United States
Envision Ocular, LLC
ACTIVE_NOT_RECRUITING

Bloomfield, New Jersey, 07003, United States
Erie Retina Research
COMPLETED

Erie, Pennsylvania, 16505, United States
Fargo Retina Consultants
ACTIVE_NOT_RECRUITING

Fargo, North Dakota, 58047, United States
Ft Lauderdale Eye Institute
WITHDRAWN

Plantation, Florida, 33324-3118, United States
Graystone Eye-Hickory - 2415 Century Pl
RECRUITING

Hickory, North Carolina, 28602, United States
Macula Retina Vitreous Research Institute
ACTIVE_NOT_RECRUITING

Torrance, California, 90503-3270, United States
Maine Eye Center
ACTIVE_NOT_RECRUITING

Portland, Maine, 04101, United States
Mid Atlantic Retina
WITHDRAWN

Philadelphia, Pennsylvania, 19107-5109, United States
Midwest Vision Research Foundation
COMPLETED

Chesterfield, Missouri, 63017-5065, United States
Orange County Retina Med Group
ACTIVE_NOT_RECRUITING

Santa Ana, California, 92705-6504, United States
Palmetto Retina Center
WITHDRAWN

Florence, South Carolina, 29501, United States
Palmetto Retina Center, LLC
WITHDRAWN

West Columbia, South Carolina, 29169-2429, United States
Panhandle Eye Group LLP Southwest Retina Specialists
COMPLETED

Amarillo, Texas, 79106-1835, United States
Piedmont Eye Center
ACTIVE_NOT_RECRUITING

Lynchburg, Virginia, 24502-4271, United States
Retina Associates of Kentucky
WITHDRAWN

Lexington, Kentucky, 40509-1827, United States
Retina Associates of Southern California
ACTIVE_NOT_RECRUITING

Huntington Beach, California, 92647, United States
Retina Associates of Utah, PLLC
ACTIVE_NOT_RECRUITING

Salt Lake City, Utah, 84107-6767, United States
Retina Consultants of Texas
ACTIVE_NOT_RECRUITING

Bellaire, Texas, 77401, United States
Retina Consultants of Texas
ACTIVE_NOT_RECRUITING

Schertz, Texas, 78154, United States
Retina Group of New England
WITHDRAWN

Waterford, Connecticut, 06385-1215, United States
Retina Group of Washington
WITHDRAWN

Chevy Chase, Maryland, 20815-6956, United States
Retina Institute of Virginia
WITHDRAWN

Richmond, Virginia, 23235-1962, United States
Retina Specialty Institute
ACTIVE_NOT_RECRUITING

Pensacola, Florida, 32503-2030, United States
Retina Vitreous Associates of Florida
ACTIVE_NOT_RECRUITING

St. Petersburg, Florida, 33711-1141, United States
Retinal Consultants Med Group
ACTIVE_NOT_RECRUITING

Sacramento, California, 95841-2013, United States
Seeta Eye Centers
ACTIVE_NOT_RECRUITING

Poughkeepsie, New York, 12603-2416, United States
Sierra Eye Associates
ACTIVE_NOT_RECRUITING

Reno, Nevada, 89502-1605, United States
Southeast Retina Center
ACTIVE_NOT_RECRUITING

Augusta, Georgia, 30909-6440, United States
Southwest Retina Consultants
COMPLETED

Durango, Colorado, 81303, United States
Spokane Eye Clinical Research
ACTIVE_NOT_RECRUITING

Spokane, Washington, 99204-2509, United States
Tennessee Retina PC
ACTIVE_NOT_RECRUITING

Nashville, Tennessee, 37203-1596, United States
The Retina Care Center
ACTIVE_NOT_RECRUITING

Baltimore, Maryland, 21209-2219, United States
Tulsa Retina Consultants
WITHDRAWN

Tulsa, Oklahoma, 74114, United States
University Retina and Macula Associates, PC
ACTIVE_NOT_RECRUITING

Lemont, Illinois, 60439-7421, United States
University of California San Francisco
ACTIVE_NOT_RECRUITING

San Francisco, California, 94158-2510, United States
VitreoRetinal Surgery, PLLC.
ACTIVE_NOT_RECRUITING

Minneapolis, Minnesota, 55435-3004, United States
Wagner Kapoor Institute
ACTIVE_NOT_RECRUITING

Norfolk, Virginia, 23502-3933, United States
Western Carolina Retinal Associate PA
WITHDRAWN

Asheville, North Carolina, 28803-2493, United States
Wilmer Eye Institute Johns Hopkins University
ACTIVE_NOT_RECRUITING

Baltimore, Maryland, 21287-0005, United States
Wolfe Eye Clinic
WITHDRAWN

West Des Moines, Iowa, 50266, United States

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