A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
Recruiting now · Phase 4
Conditions studied: Neovascular Age-related Macular Degeneration
In brief
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Key facts
- Study ID
- NCT04853251
- Run by
- Genentech, Inc.
- People needed
- 188
- Starts
- 2021-12-14
- Expected to finish
- 2027-10-29
- Last updated by the study team
- 2026-07-10
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cincinnati Eye Institute — Blue Ash, Ohio, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Seeta Eye Centers — Poughkeepsie, New York, United States (enrolling)
- Fargo Retina Consultants — Fargo, North Dakota, United States (enrolling)
- Retina Associates of Southern California — Huntington Beach, California, United States (enrolling)
- Orange County Retina Med Group — Santa Ana, California, United States (enrolling)
- Sierra Eye Associates — Reno, Nevada, United States (enrolling)
- Envision Ocular, LLC — Bloomfield, New Jersey, United States (enrolling)
- Advanced Vision Research Institute — Longmont, Colorado, United States (enrolling)
- Graystone Eye — Hickory, North Carolina, United States (enrolling)
- Retina Specialty Institute — Pensacola, Florida, United States (enrolling)
- University of California San Francisco — San Francisco, California, United States (enrolling)
- Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States (enrolling)
- Southeast Retina Center — Augusta, Georgia, United States (enrolling)
- University Retina and Macula Associates, PC — Lemont, Illinois, United States (enrolling)
- Macula Retina Vitreous Research Institute — Torrance, California, United States (enrolling)
- Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States (enrolling)
- Maine Eye Center — Portland, Maine, United States (enrolling)
- The Retina Care Center — Baltimore, Maryland, United States (enrolling)
- Wilmer Eye Institute Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
- Retinal Consultants Med Group — Sacramento, California, United States (enrolling)
- Duke Eye Center — Durham, North Carolina, United States (enrolling)
- Associated Retinal Consultants PC — Royal Oak, Michigan, United States (enrolling)
- VitreoRetinal Surgery, PLLC. — Minneapolis, Minnesota, United States (enrolling)
- Charles Retina Institute — Germantown, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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