Long-term outcomes in wet AMD not predicted by month 3 vision outcomes
Patient-level data showed month 3 vision outcomes did not predict long-term neovascular age-related macular degeneration outcomes when treated with ranibizumab, according to presentation at the virtual American Society of Retina Specialists meeting.
“In this analysis, we explored the HARBOR data to address the key question: Do month 3 vision outcomes in patients with neovascuar AMD predict long-term outcomes? Particularly as novel mechanism therapeutics are being developed for neovascular AMD, the answer to this question may inform optimal timing for switching to novel treatments,” Paul Hahn, MD, PhD, of NJRetina in Teaneck, NJ, said in his presentation.
To determine whether month 3 responses after three ranibizumab injections predicted long-term neovascular AMD outcomes, Hahn and colleagues pooled data from 1,057 neovascular AMD patients treated with ranibizumab (0.5 mg/2 mg; monthly/as needed). Then, they grouped patients into different response ‘lanes’ based on best-corrected visual acuity (BCVA) response at month 3: improvement by less than 5 letters, 5 to 9 letters and 10 or more letters.
Researchers evaluated the mean change in BCVA at month 3 and month 24, average BCVA over time by BCVA response at month 3 and changes in central foveal thickness for all pooled treatment groups who received ranibizumab.
Analysis showed that BCVA improved by less than 5 letters in 376 patients, by 5 to 9 letters in 213 patients and by at least 10 letters in 468 patients at month 3.
When the researchers plotted the mean change in BCVA at a population level, they found that month 3 vision change seemed to predict long-term response, with patients remaining in their ‘lanes’ through month 24, but when plotted at the individual patient level, they reported notable movement between ‘lanes.’
“Although population-level data suggest that month 3 vision outcomes are predictive of long-term outcomes in neovascular AMD, individual patient-level data demonstrate that month 3 outcomes are not predictive of long-term outcomes,” Hahn said. “In fact, nearly 40% of patients changed BCVA ‘lanes’ after month 3, with approximately 60% of those showing vision improvement.”
The month 24 data showed that 38% of patients who gained less than 5 letters at month 3 had changed ‘lanes’ – with 21% gaining at least 10 letters, while 80% of patients who gained 5 to 9 letters had shifted either up or down ‘lanes,’ the data showed. Of those who gained at least 10 letters at month 3, 80% stayed in ‘lane’ and 11% declined to less than 5 letters at month 34.
By month 24, 38% of patients switched lanes and researchers observed major reductions in central foveal thickness in all patients by month 3, which was maintained through month 24.
While baseline characteristics were similar in patients with less than 5 letters and 5 to 9 letters ‘lanes,’ those who gained at least 10 letters at month 3 were younger, had smaller lesion size, worse BCVA and thicker retinas, according to the presentation.
“As novel mechanism treatments are likely to become available in the foreseeable future, this study suggests that further biomarkers are needed to predict long-term outcomes as well as optimal timing for switching to such novel mechanism treatments when become available,” Hahn concluded.
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Hahn P, et al. Predicting long-term response to ranibizumab after three injections in patients with age-related macular degeneration. Presented at: ASRS annual meeting; July 24-26, 2020 (virtual meeting).
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