Ophthalmology. Retina · 2026
Pooled Analyses of Anatomic and Visual Function Data of Revakinagene Taroretcel-lwey in Participants with Macular Telangiectasia Type 2.
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Goldberg Roger A, Manning Debora C, Yankey Joanna, Clark W Lloyd, Bitar Muna I, Chew Emily Y, Friedlander Martin, Khanani Arshad M, Jaffe Glenn J, Lad Eleonora M, Aaberg Thomas M, MacTel Study Group
Аннотация
PURPOSE: To assess anatomic and visual function data from 3 randomized, sham-controlled clinical trials of revakinagene taroretcel-lwey in participants with macular telangiectasia type 2 (MacTel).
DESIGN: This study pooled data from 1 phase II (NTMT-02) clinical trial and 2 identically designed phase III (NTMT-03-A and NTMT-03-B) clinical trials of revakinagene taroretcel-lwey in MacTel.
PARTICIPANTS: In total, 67 participants (99 eyes) from NTMT-02, 115 participants (115 eyes) from NTMT-03-A, and 113 participants (113 eyes) from NTMT-03-B were included in the study. The pooled population included 327 eyes from 295 participants (165 participants who received revakinagene taroretcel-lwey and 162 who underwent sham surgical procedure).
METHODS: Assessments were conducted on data from the individual trials as well as on a single pooled population from all 3 trials.
MAIN OUTCOME MEASURES: The rate of ellipsoid zone (EZ) area loss over 24 months and changes from baseline in monocular reading speed loss, aggregate retinal sensitivity loss measured by microperimetry, and best-corrected visual acuity (BCVA) were assessed.
RESULTS: In the pooled analysis, a 36.2% reduction in the rate of EZ area loss over 24 months was observed with revakinagene taroretcel-lwey (0.118 mm2/24 months; 95% confidence interval [CI], 0.087-0.149) versus sham (0.185 mm2/24 months; 95% CI, 0.154-0.217) (nominal P = 0.003). A 68.2% reduction in monocular reading speed loss at 24 months from baseline was observed with revakinagene taroretcel-lwey (-4.65 words per minute [WPM]; 95% CI, -9.58 to -0.27) versus sham (-14.60 WPM; 95% CI, -20.41 to -8.79) (nominal P = 0.01). Across the 3 trials, a 36.6% reduction in aggregate retinal sensitivity loss was reported over 24 months with revakinagene taroretcel-lwey (28.47 dB; 95% CI, 6.62-50.31) compared with sham (44.85 dB; 95% CI, 36.99-52.72) (nominal P < 0.001). Both treatment groups experienced minimal changes in BCVA over 24 months.
CONCLUSIONS: In this pooled analysis, revakinagene taroretcel-lwey reduced the rate of MacTel disease progression and preserved visual function over 24 months, as shown by reductions in the rate of EZ area loss, reading speed loss, and aggregate retinal sensitivity loss.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
DESIGN: This study pooled data from 1 phase II (NTMT-02) clinical trial and 2 identically designed phase III (NTMT-03-A and NTMT-03-B) clinical trials of revakinagene taroretcel-lwey in MacTel.
PARTICIPANTS: In total, 67 participants (99 eyes) from NTMT-02, 115 participants (115 eyes) from NTMT-03-A, and 113 participants (113 eyes) from NTMT-03-B were included in the study. The pooled population included 327 eyes from 295 participants (165 participants who received revakinagene taroretcel-lwey and 162 who underwent sham surgical procedure).
METHODS: Assessments were conducted on data from the individual trials as well as on a single pooled population from all 3 trials.
MAIN OUTCOME MEASURES: The rate of ellipsoid zone (EZ) area loss over 24 months and changes from baseline in monocular reading speed loss, aggregate retinal sensitivity loss measured by microperimetry, and best-corrected visual acuity (BCVA) were assessed.
RESULTS: In the pooled analysis, a 36.2% reduction in the rate of EZ area loss over 24 months was observed with revakinagene taroretcel-lwey (0.118 mm2/24 months; 95% confidence interval [CI], 0.087-0.149) versus sham (0.185 mm2/24 months; 95% CI, 0.154-0.217) (nominal P = 0.003). A 68.2% reduction in monocular reading speed loss at 24 months from baseline was observed with revakinagene taroretcel-lwey (-4.65 words per minute [WPM]; 95% CI, -9.58 to -0.27) versus sham (-14.60 WPM; 95% CI, -20.41 to -8.79) (nominal P = 0.01). Across the 3 trials, a 36.6% reduction in aggregate retinal sensitivity loss was reported over 24 months with revakinagene taroretcel-lwey (28.47 dB; 95% CI, 6.62-50.31) compared with sham (44.85 dB; 95% CI, 36.99-52.72) (nominal P < 0.001). Both treatment groups experienced minimal changes in BCVA over 24 months.
CONCLUSIONS: In this pooled analysis, revakinagene taroretcel-lwey reduced the rate of MacTel disease progression and preserved visual function over 24 months, as shown by reductions in the rate of EZ area loss, reading speed loss, and aggregate retinal sensitivity loss.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.