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

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

What this study is about