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Area of Science:

  • Ophthalmology
  • Regenerative Medicine
  • Clinical Trials

Background:

  • Macular Telangiectasia type 2 (MacTel) is a progressive retinal degeneration.
  • Revakinagene taroretcel (NT-501) is an encapsulated cell therapy delivering ciliary neurotrophic factor.
  • Phase 2 trials indicated NT-501 slowed retinal degeneration in MacTel patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of NT-501 in treating MacTel.
  • To assess the impact of NT-501 on photoreceptor loss (ellipsoid zone area).
  • To investigate secondary outcomes including visual function and safety endpoints.

Main Methods:

  • Two identically designed, multicenter, randomized sham-controlled phase 3 trials (NTMT-03-A and NTMT-03-B).
  • Primary endpoint: Rate of ellipsoid zone area (EZA) loss over 24 months.
  • Secondary endpoints: Retinal sensitivity, reading speed, NEI VFQ-25 scores, best-corrected visual acuity (BCVA), and adverse events.

Main Results:

  • NT-501 significantly reduced EZA loss compared to sham in both trials (NTMT-03-A: -0.091 mm²/24 months, P<0.001; NTMT-03-B: -0.049 mm²/24 months, P=0.02).
  • Changes in retinal sensitivity and reading speed were inconsistent between groups.
  • No significant differences in NEI VFQ-25 scores, BCVA loss, or serious adverse events were observed; miosis and delayed dark adaptation were noted with NT-501.

Conclusions:

  • NT-501 demonstrated statistically significant reduction in EZA loss in MacTel patients compared to sham.
  • The findings support NT-501 as a potential therapeutic option for MacTel.
  • Further monitoring for specific adverse events like miosis and delayed dark adaptation is warranted.