Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Ki vehet részt

• Able to provide voluntary written informed consent on the approved ICF, understand the study requirements, and are willing to follow and complete all the study required procedures
• Male or female aged ≥ 50 years
• As per the Investigator's judgment, patients with active CNV lesions (ie, foveal or parafoveal) secondary to nAMD, as confirmed with SD-OCT, FFA, and fundus photography (FP) in the study eye. Patients must have received at least two prior anti-VEGF doses (eg, aflibercept, ranibizumab, bevacizumab, brolicizumab, or faricimab), meeting criteria for non-ideal response
• Active CNV lesions, secondary to nAMD as confirmed with SD-OCT (or SS-OCT), FFA and fundus photography (FP) in the study eye
• BCVA score of between 73 and 21 letters, inclusive, in the study eye using ETDRS testing (Snellen equivalent score between 20/40 and 20/400, inclusive
• Participant has CST > 250 μm if measured by Cirrus OCT or > 270 μm if measured by Spectralis OCT, with presence of intraretinal and/or subretinal fluid
• Participants who have had a washout period of at least six weeks prior to first administration of the IMP for any IVT anti-VEGF medication and, who in the opinion of the investigator, have disease sufficiently stable to enable this interval

Ki nem vehet részt

• Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study
• Glaucoma, evidenced by an IOP of > 21 mmHg despite up to 4 glaucoma medications, or evidence of glaucomatous visual field loss or has advanced glaucoma (e.g., prior shunt surgery) in either eye
• Need for ocular surgery in the study eye during the course of the study
• YAG laser capsulotomy within 30 days prior to Visit 1 in the study eye
• Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 in the study eye
• Evidence of any other ocular disease other than nAMD in the study eye that may confound the outcome of the study (eg, active diabetic retinopathy, posterior uveitis, pseudovitelliform macular degeneration, moderate/severe myopia)
• Participants with advanced nAMD and no prognosis of BCVA as per Investigator's judgement (e.g. due to macular OCT signs of atrophy or photoreceptors disruption, or macular/foveal subretinal hemorrhage)
• Ocular or periocular infection in either eye
• History of herpetic infection in the study eye or adnexa
• Presence of any form of ocular malignancy including choroidal melanoma in either eye
• Use of any of the following treatments or anticipated use of any of the following treatments to the study eye:
• Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye
• Media opacity that would limit clinical visualization, intravenous fluorescein angiography, or spectral-domain optical coherence tomography (SD-OCT) evaluation in the study eye
• Presence of known active toxoplasmosis, inactive toxoplasmosis or toxoplasmosis scar in either eye