Estudio de fase III, multicéntrico, aleatorizado, de doble enmascaramiento y controlado con inyección simulada, de 24 meses de duración, para evaluar la eficacia y seguridad de múltiples inyecciones intravítreas (IVT) de APL-2 en sujetos con AG secundaria a DMAE.

Elegibilidad

Edad mínima: 60 YearsSexo: ALL

Criterios de inclusión

Age ≥ 60 years.
Normal Luminance best corrected visual acuity of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent).
Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.
The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:
Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas \[DA\] respectively)
If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 4a.
The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
Female subjects must be:
Women of non-child-bearing potential (WONCBP), or
Women of child-bearing potential (WOCBP) with a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
Willing and able to give informed consent and to comply with the study procedures and assessments.

Criterios de exclusión

GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
Spherical equivalent of the refractive error demonstrating \> 6 diopters of myopia or an axial length \>26 mm.
Any history or active choroidal neovascularization (CNV), associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center.
Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function, including but not limited to, uveitis, other macular diseases (e.g. clinically significant epiretinal membrane (ERM), full thickness macular hole or uncontrolled glaucoma/ocular hypertension. Benign conditions in the opinion of the investigator such as peripheral retina dystrophy are not exclusionary).
Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
History of laser therapy in the macular region.
Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
Any contraindication to IVT injection including current ocular or periocular infection.
History of prior intravitreal injection.
Prior participation in another interventional clinical study for intravitreal therapies in either eye (including subjects receiving sham).
Prior participation in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo.
Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24-month treatment period unlikely, or would make the subject an unsafe study candidate.
Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.

Ubicaciones

Fundacion Zambrano

Buenos Aires, Buenos Aires F.D., Argentina

Microcirugia Ocular

El Rosario, Corrientes Province, Argentina

Grupo Laser Vision

Rosario, Santa Fe Province, Argentina

Organizacion Medica de investigacion

Buenos Aires, Argentina

Centro Oftalmologico Dr Charles

Buenos Aires, Argentina

Diagnostico Ocular

Buenos Aires, Argentina

Centro Privado de Ojos Romagosa SA

Córdoba, Argentina

Instituto Oftalmologico de Cordoba

Córdoba, Argentina

Oftar Mendoza SRL

Mendoza, Argentina

Oftalmologos Especialistas

Rosario, Argentina

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

APL-2

APL-2

Sham Procedure

Sham Procedure

Ubicaciones

Fundacion Zambrano

Microcirugia Ocular

Grupo Laser Vision

Organizacion Medica de investigacion

Centro Oftalmologico Dr Charles

Diagnostico Ocular

Centro Privado de Ojos Romagosa SA

Instituto Oftalmologico de Cordoba

Oftar Mendoza SRL

Oftalmologos Especialistas

Patrocinadores