Resumen

Este estudio evaluará la seguridad y tolerabilidad a largo plazo del Sistema de Administración Portuaria con ranibizumab (PDS) (100 mg/mL) en participantes con degeneración macular asociada a la edad neovascular (DMAE-n) que hayan completado el Estudio de Fase II GX28228 (Ladder), el Estudio de Fase III GR40548 (Archway), el Estudio de Fase IIIb WR42221 (Velodrome), o que hayan completado la visita de la Semana 24 en el Estudio WR42221 pero no hayan sido elegibles para la aleatorización en dicho estudio.

Descripción detallada

El subestudio de fotocoagulación transescleral (subestudio 1) evaluará la efectividad del uso de la fotocoagulación transescleral (TPC) con el sistema láser Iridex para mitigar las hemorragias vítreas secundarias al procedimiento de implantación del Sistema de Administración Portuaria con ranibizumab (PDS) en participantes con degeneración macular asociada a la edad neovascular (DMAE-n). El subestudio incluirá a aproximadamente 55 participantes. El subestudio de reimplantación (subestudio 2) evaluará la seguridad de la reimplantación con el PDS con ranibizumab actualizado. Se incluirán hasta 100 participantes que hayan participado previamente en el estudio principal en los Estados Unidos y serán seguidos durante un máximo de 72 semanas tras la reimplantación en el subestudio.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
Ability and willingness to undertake all scheduled visits and assessments
For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
\- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
Participants must meet the following ocular criteria for the study eye for substudy entry:
Diagnosis of exudative nAMD within 2 years prior to the enrollment visit
Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit
Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following:
Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA)
All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea).
Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP and SD-OCT images.
Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center

Criterios de exclusión

Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab
History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications
History of other diseases, 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 that renders the participant at high risk of treatment complications
Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"
Sub-study 1
History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
Previous treatment with corticosteroid ITV injection
Previous intraocular device implantation
Previous laser (any type) used for AMD treatment
Either Eye
Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit
Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab
CNV Lesion Charateristics Study Eye
Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening
Subfoveal fibrosis or subfoveal atrophy
Either Eye
\- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Concurrent Ocular Conditions Study Eye
Retinal pigment epithelial tear
Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) 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
Active intraocular inflammation (grade trace or above)
History of vitreous hemorrhage
History of rhegmatogenous retinal detachment
History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
Aphakia or absence of the posterior capsule
Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (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
Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye
Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit
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
History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
History of corneal transplant
History of prior vitrectomy surgery and absence of posterior capsule
Either Eye
History of idiopathic or autoimmune-associated uveitis
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
Concurrent Systemic Conditions
Inability to comply with study schedule or procedures as described in the study protocol
Uncontrolled blood pressure
History of stroke within the last 3 months prior to informed consent
Uncontrolled atrial fibrillation within 3 months of 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 patient at high risk of treatment complications in the opinion of the investigator
Current systemic treatment for a confirmed active systemic infection
Use of any systemic anti-VEGF agents
Chronic use of oral corticosteroids
Active cancer within 12 months of enrollment
Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
History of albinism
Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab
Sub-study 2
Concurrent Ocular Conditions-Study Eye
Any ocular condition that may render the patient at high risk for surgical or treatment complications
Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant
Ongoing ocular complications that might affect participant safety
Concurrent Ocular Conditions-Either Eye
Suspected or active ocular or periocular infection
Any history of uveitis
Active blepharitis
Concurrent Systemic Conditions
Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications
Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in the main study GR40549) within 6 months prior to enrollment.
Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.

Estudio de extensión abierto y multicéntrico para evaluar la seguridad y tolerabilidad a largo plazo del Sistema de Administración Portuaria con ranibizumab en pacientes con degeneración macular asociada a la edad neovascular (Portal)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

PDS Implant with Ranibizumab 100 mg/mL

Ubicaciones

Oftalmos

Centro Oftalmologico Dr. Charles S.A.

Grupo Laser Vision

Patrocinadores

Contactos

Reference Study ID Number: GR40549 https://forpatients.roche.com/