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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

A Phase IV, Multicenter, Open-label Study to Assess Corneal Endothelial Cells in Patients With Neovascular Age-related Macular Degeneration Treated With the Port Delivery System With Ranibizumab (PDS)

A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS) (NCT04853251) is a Phase 4 interventional studying Neovascular Age-related Macular Degeneration, sponsored by Genentech, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 188 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Neovascular Age-related Macular Degeneration subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Criteria Ocular Who May Qualify: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

PDS Implant With Ranibizumab 100 mg/ml

Ranibizumab 100 mg/mL will be delivered via PDS

DRUG

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.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04853251), the sponsor (Genentech, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04853251 clinical trial studying?

This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04853251?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04853251?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04853251. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04853251. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.