Ensayo Clínico de Fase 3, Aleatorizado, Doble Enmascarado, Controlado Activo con una Sola Inyección Intravítrea de 4D-150 en Adultos con Neovascularización Macular Secundaria a Degeneración Macular Relacionada con la Edad

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07064759Tipo: INTERVENTIONALInicio: 22 de jul de 2025Fin estimado: 1 de feb de 2029

Resumen

Ensayo clínico de Fase 3, aleatorizado, doble enmascarado, controlado activo en adultos con neovascularización macular secundaria a degeneración macular relacionada con la edad.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

≥50 years of age at time of consent
MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:
Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator
Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center
Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center
BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit
CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center

Criterios de exclusión

Ocular Conditions:
MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)
History of retinal detachment in the study eye
History of or presence of active inflammation in either eye
Glaucoma or intraocular hypertension requiring more than 2 topical medications for control
Ocular Treatments/Interventions:
Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye
Systemic Conditions and Considerations:
Major illness or major surgical procedure in the 28 days prior to the Screening Visit
Uncontrolled blood pressure
Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit
History of autoimmune condition that may predispose to the development of uveitis

Intervenciones

biological

4D-150 IVT (3E10 vg/eye)

If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1

biological

EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Eylea (aflibercept) will be administered at applicable visits

Ubicaciones

Charles Research Center

Buenos Aires, Argentina

Patricio Gerardo Schlottmann, MD

RECRUITING

Patrocinadores

Principal4D Molecular Therapeutics

Contactos

4DMT Patient Advocacy

CONTACT

clinicaltrials@4DMT.com (888) 748-8881

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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