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Reading speed suitable outcome measure for lampalizumab trials
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MIAMI — Results of the MAHALO study support the use of reading speed as a secondary outcome measure in clinical trials for lampalizumab, a speaker told colleagues here.
Lampalizumab (Roche) is a monoclonal antibody fragment that targets factor D and inhibits the progression of geographic atrophy.
Brandon G. Busbee
“We feel that the results of MAHALO support the use of reading speed as an outcome measure in clinical trials of [geographic atrophy]. As the next few years go by, we’ll have a substantial amount of data on the accuracy and the impact it has on defining visual function,” Brandon G. Busbee, MD, said at Angiogenesis, Exudation, and Degeneration 2016.
Best corrected visual acuity alone often underestimates the effect of geographic atrophy on visual function and vision-related quality of life, Busbee said.
“We do know that there’s a common complaint with these patients. There’s difficulty reading,” he said.
In the MAHALO study, investigators used MNREAD acuity charts to gauge reading speed. Maximum reading speed is the average of the three highest reading speed values in words per minute (WPM). Spot reading is 40 WPM, fluent reading is 80 WPM, and highly fluent reading is 160 WPM, Busbee said.
Median reading speed declined from 99 WPM to 74 WPM over the 18-month trial period, Busbee said.
The greatest decline in reading speed occurred between 12 months and 18 months.
Rapidly progressing lesions were associated with a greater reduction in reading speed compared with slower-growing lesions at 18 months, Busbee said.
Limitations of the MAHALO study included a small patient group; results need to be corroborated in larger studies, he said.
Reading speed is being evaluated in four ongoing lampalizumab studies: Chroma, Spectri, Proxima A and Proxima B. The studies are also evaluating visual acuity, low-light vision and microperimetry, Busbee said. – by Matt Hasson and Kristie L. Kahl
Disclosure: Busbee reports he is a consultant/advisor to Aerpio, Genentech, Regeneron and Valeant. He receives grant support from Genentech and Regeneron and patent royalties from Alcon.