*Twelve months: (95% CI) mm2/year=0.67 (0.21-1.13).
Six months: (95% CI) mm2/year=0.323 (0.068-0.579).1
†Twelve months: (95% CI) mm2/year=0.38 (0.12-0.63).
Six months: (95% CI) mm2/year=0.188 (0.061, 0.315).1
- Given the exploratory post hoc nature of the data, these results should be interpreted with caution and cannot be considered conclusive. This is a simplified piecewise slope spline multivariate and repeated measures analysis
Trial Design: Efficacy and safety of IZERVAY were evaluated in 2 phase 3, randomized, multicenter, double-masked, sham-controlled clinical trials. 292 patients were treated with IZERVAY 2 mg, and 332 patients received sham. The primary endpoint in GATHER1 (n=177) and GATHER2 (n=447) was the mean rate of GA growth (slope) from baseline to Month 12, measured by fundus autofluorescence (FAF) at 3 time points: baseline, Month 6, and Month 12.1
IZERVAY post hoc analysis showed fewer patients lost driving eligibility compared to sham15
In a pooled post hoc analysis of the GATHER trials, fewer patients on IZERVAY fell below driving vision threshold of 20/40 at or up to 12 months compared to sham
The absolute low vision BCVA cutoff varies by state in the United States. The cutoff for loss of legal driving vision in this post hoc analysis was eyes with a baseline of ≥70 letters (20/40) that progressed to ≤60 letters (20/63) at or up to month 12. Persistent loss of driving vision was defined as patients who progressed to ≤60 letters at 2 consecutive post-baseline visits.
- There are a number of factors that determine a patient's ability to drive and this decision should be considered carefully by each patient and their doctor
- Given the exploratory post hoc nature of the data, these results should be interpreted with caution and cannot be considered conclusive
IZERVAY post hoc analysis signaled reduction in risk of vision loss compared to sham15
Persistent vision loss in this pooled analysis from the GATHER clinical trials was defined as a loss of ≥15 letters (ETDRS) in BCVA from baseline measured at any 2 consecutive visits up to Month 12, with a 56% risk reduction in persistent vision loss with IZERVAY vs sham.
- Masked image and adverse event analysis completed to further ensure vision loss was consistent with disease progression
- Given the exploratory post hoc nature of the data, these results should be interpreted with caution and cannot be considered conclusive
IZERVAY was evaluated in patients with GA secondary to age-related macular degeneration (AMD)1
The efficacy and safety of IZERVAY were evaluated in 2 randomized, multi-center, double-masked, sham-controlled clinical trials.1
In GATHER1 and GATHER2, patients were randomized to receive either intravitreal injections of IZERVAY or sham once monthly.
Baseline patient demographics4,16
Baseline characteristics were balanced across trials and treatment arms
Scroll left to view more.
|
GATHER1
IZERVAY
(n=67)
|
GATHER1
Sham
(n=110)
|
GATHER2
IZERVAY
(n=225)
|
GATHER2
Sham
(n=222)
|
|
|---|---|---|---|---|
| Mean age, years (SD) | 78.8 (10.2) | 78.2 (8.8) | 76.3 (8.6) | 76.7 (8.8) |
| Female, n (%) | 45 (67.2) | 79 (71.8) | 154 (68) | 156 (70) |
| Caucasian, n (%) | 67 (100) | 107 (97.3) | 182 (81) | 186 (84) |
| Active smoker, n (%) | 25 (37.3) | 36 (32.7) | 106 (47) | 107 (48) |
| Mean total GA area, mm2 (SD)* | 7.33 (3.79) | 7.42 (3.84) | 7.48 (4.00) | 7.81 (3.89) |
| Mean square root GA area, mm2 (SD)* | 2.62 (0.70) | 2.63 (0.70) | 2.64 (0.71) | 2.71 (0.70) |
| Bilateral GA, n (%) | 67 (100) | 108 (98.2) | 212 (94) | 210 (95) |
| Mean BCVA, letters (SD)* | 70.2 (10.0) | 69.0 (10.4) | 70.9 (8.9) | 71.6 (9.4) |
| Mean LL-BCVA letters (SD)* | 36.7 (21.1) | 34.5 (19.3) | 41.0 (19.7) | 39.6 (19.6) |
BCVA=best corrected visual acuity.
Additional inclusion criteria3,4
- ≥50 years
- BCVA between 20/25 and 20/320
- GA lesions:
- Total area between 2.5 mm2 and 17.5 mm2 (1-7 DA, respectively)
- If multifocal lesions, at least 1 lesion had to be 1.25 mm2 (0.5 DA)
Additional exclusion criteria3,4
- Evidence of choroidal neovascularization (CNV) or any sign of diabetic retinopathy in either eye at baseline
- GA secondary to any condition other than AMD in either eye
- Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye (except oral vitamin or mineral supplements)
- Any ocular condition in study eye that could progress during the study and potentially affect central vision or otherwise act as a confounding factor
- MMRM=mixed models for repeated measures.
- Percent difference is calculated by 100*(difference)/(least square mean from sham).
