Table 1.
Inclusion criteria | |
1 | Men and women aged ≥50 years |
2 | Active treatment‐naïve primary subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affected the fovea, as evidenced by fluorescein angiography |
3 | Area of CNV occupying at least 50% of total lesion, as determined by fluorescein angiography |
4 | Evidence of intraretinal and/or subretinal fluid on optical coherence tomography in the study eye |
5 | Best‐corrected visual acuity between 73 and 25 Early Treatment Diabetic Retinopathy Study letters (Snellen activity equivalent of 20/40 to 20/320) in the study eye |
6 | Ability to complete all study‐related procedures |
Exclusion criteria | |
1 | Concurrent disease in the study eye, other than AMD, that could compromise visual acuity |
2 | Any findings in the study eye that would limit the potential to benefit from study treatment, or could otherwise confound interpretation of the results, such as total lesion size (including structural damage to the centre of the macula, neovascularization, scar, blood) >12 disc areas (30.5 mm2) and subfoveal fibrosis, as assessed by fluorescein angiography |
3 | Only one functional eye |
4 | Prior ocular or systemic treatment or surgery for nAMD in the study eye, except dietary supplements or vitamins |
5 | Prior treatment with any systemic anti‐vascular endothelial growth factor agent, cataract surgery or any other surgery in the study eye within 12 weeks prior to start of study treatment |
6 | History or current use of long‐acting steroids, either systemically or injected intraocularly, periocularly or subconjunctivally |
7 | Intraocular pressure ≥25 mmHg in the study eye |
8 | Uncontrolled glaucoma |
9 | Any other condition that would require frequent chronic co‐administration of other topical eye medications that would interfere with study drug administration (e.g. contact lens) |
10 | Uncontrolled hypertension |
11 | Women of childbearing potential |
AMD, age‐related macular degeneration; CNV, choroidal neovascularization; nAMD, neovascular AMD