Eyes that Do Not Meet the Eligibility Criteria of Clinical Trials on Age-Related Macular Degeneration: Proportion of the Real-World Patient Population and Reasons for Exclusion
Table 3
Eligibility criteria of the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD studies used for result analysis (category 3) and the number of eyes that did not meet the inclusion criteria or that met the exclusion criteria.
Characteristic
Total (N = 512)
Inclusion Criteria
1) Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
8 (1.6%)
2) CNV must be at least 50% of total lesion size.
25 (4.9%)
3) ETDRS best-corrected visual acuity of 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
169 (33.0%)
Exclusion Criteria
4) Total lesion size > 12 disc areas (30.5 mm2), including blood, scars, and neovascularization as assessed by FA in the study eye.
13 (2.5%)†
5) Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270° by visible CNV.)
47 (9.2%)†
6) Scar or fibrosis, making up > 50% of total lesion in the study eye.
9 (1.8%)†
7) Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
12 (2.3%)†
8) Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
2 (0.4%)†
9) History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any other vascular disease affecting the retina, other than AMD, in either eye.
15 (2.9%)†
10) Any concurrent intraocular condition in the study eye (e.g., cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 96-week study period.
4 (0.8%)†
11) Prior vitrectomy in the study eye.
2 (0.4%)†
12) Any history of macular hole of stage 2 and above in the study eye.
0†
13) Any intraocular or periocular surgery within 3 months of day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it is unlikely to interfere with the injection.
0†
14) Prior trabeculectomy or another filtration surgery in the study eye.
0†
15) Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
2 (0.4%)†
16) Active intraocular inflammation in either eye.
0†
17) Active ocular or periocular infection in either eye.
0†
18) Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of an yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye.
0†
19) History of corneal transplant or corneal dystrophy in the study eye.
0†
VEGF = vascular endothelial growth factor, AMD = age-related macular degeneration, CNV = choroidal neovascularization, FA = fluorescein angiography, ETDRS = Early Treatment Diabetic Retinopathy Study. : Number of eyes that did not meet the inclusion criteria. †: Number of eyes that met the exclusion criteria.
