A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 be 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)
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
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
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
