Resumen

El estudio WR42221 es un estudio de fase IIIb, global, multicéntrico, aleatorizado, con enmascaramiento del evaluador visual, diseñado para evaluar la eficacia, seguridad y farmacocinética del Sistema de Administración por Puerto con ranibizumab (PDS) 100 mg/mL administrado cada 36 semanas (Q36W) en comparación con cada 24 semanas (Q24W) en pacientes con degeneración macular asociada a la edad neovascular (DMAEn).

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Age ≥ 50 years at time of signing Informed Consent Form
Initial diagnosis of nAMD within 9 months prior to the screening visit
Previous treatment with at least three anti- vascular endothelial growth factor (VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment
BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better

Criterios de exclusión

History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
Previous treatment with corticosteroid intravitreal injection, intraocular device implantation, previous laser (any type) used for AMD treatment in study eye
Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit in study eye
Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
Prior treatment with brolucizumab (at any time prior to the screening visit) in either eye
Prior participation in a clinical trial involving any anti-VEGF drugs, within 9 months prior to the enrollment visit in either eye
Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is \>0.5 disc area at screening in study eye
Subfoveal fibrosis or subfoveal atrophy in study eye
Choroidal neovascularization (CNV) due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia in either eye
Retinal pigment epithelial tear in study eye
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 in study eye
Active intraocular inflammation in study eye
History of vitreous hemorrhage in study eye
History of rhegmatogenous retinal detachment in study eye
History of retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit in study eye
History of pars plana vitrectomy surgery
Aphakia or absence of the posterior capsule in study eye
Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in study eye
Preoperative refractive error that exceeded 8 diopters of myopia, for Participants who have undergone prior refractive or cataract surgery in study eye
Intraocular surgery within 3 months preceding the enrollment visit in study eye
Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study in study eye
History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in study eye
History of corneal transplant in study eye
Any history of uveitis requiring treatment in either eye
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Uncontrolled blood pressure
History of stroke within the last 3 months prior to informed consent
Atrial fibrillation diagnosed or worsened within the last 3 months prior to informed consent
History of myocardial infarction within the last 3 months prior to informed consent,
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 participant at high risk of treatment complications in the opinion of the investigator
Confirmed active systemic infection
Use of any systemic anti-VEGF agents
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 disease studies of investigational drugs within 1 month preceding the informed consent
Non-functioning non-study eye

Intervenciones

drug

Ranibizumab

Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals

device

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Ranibizumab

Port Delivery System with Ranibizumab

Ubicaciones

Centro Oftalmologico Dr. Charles S.A.

Oftalmos

Grupo Laser Vision

Patrocinadores