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ROBIN: a randomised, double-masked, placebo-controlled Phase IIa study of the AOC3 inhibitor BI 1467335 in diabetic retinopathy.

Publication ,  Journal Article
Dong Nguyen, Q; Ehlers, JP; Boyer, DS; Jin, X; Giani, A; Ehrlich, MS; ROBIN study investigators
Published in: Eye (Lond)
July 2024

OBJECTIVE: To evaluate the safety and efficacy of BI 1467335 in patients with non-proliferative diabetic retinopathy (NPDR). METHODS: ROBIN is a Phase IIa, double-masked, randomised, placebo-controlled study (NCT03238963). Patients with NPDR and without centre-involved diabetic macular oedema were included; all had a best corrected visual acuity letter score of ≥70 Early Treatment Diabetic Retinopathy Study letters in the study eye at screening. Patients received oral BI 1467335 10 mg or placebo once daily for 12 weeks. Post-treatment follow-up was 12 weeks. The primary endpoint was the proportion of patients over the 24 weeks with ocular adverse events (AEs). Secondary endpoints were the proportion of patients with ≥2-step improvement from baseline in DRSS severity level at Week 12 and the proportion of patients with non-ocular AEs at 24 weeks. RESULTS: Seventy-nine patients entered the study (BI 1467335, n = 40; placebo, n = 39). The proportion of patients with ocular AEs over 24 weeks was greater in the BI 1467335 versus the placebo group (35.0% vs 23.1%, respectively). Treatment-related AEs were reported for similar numbers of patients in the placebo and BI 1467335 group (7.7% vs 7.5%, respectively). At Week 12, 5.7% (n = 2) of patients in the BI 1467335 group had a 2-step improvement in DRSS severity level from baseline, compared with 0% in the placebo group. CONCLUSIONS: BI 1467335 was well tolerated by patients with NPDR. There was a high variability in DRSS levels for individual patients over time, with no clear efficacy signal.

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Published In

Eye (Lond)

DOI

EISSN

1476-5454

Publication Date

July 2024

Volume

38

Issue

10

Start / End Page

1861 / 1869

Location

England

Related Subject Headings

  • Visual Acuity
  • Treatment Outcome
  • Ophthalmology & Optometry
  • Middle Aged
  • Male
  • Humans
  • Female
  • Double-Blind Method
  • Diabetic Retinopathy
  • Aged
 

Citation

APA
Chicago
ICMJE
MLA
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Dong Nguyen, Q., Ehlers, J. P., Boyer, D. S., Jin, X., Giani, A., Ehrlich, M. S., & ROBIN study investigators. (2024). ROBIN: a randomised, double-masked, placebo-controlled Phase IIa study of the AOC3 inhibitor BI 1467335 in diabetic retinopathy. Eye (Lond), 38(10), 1861–1869. https://doi.org/10.1038/s41433-024-03017-0
Dong Nguyen, Quan, Justis P. Ehlers, David S. Boyer, Xidong Jin, Andrea Giani, Michael S. Ehrlich, and ROBIN study investigators. “ROBIN: a randomised, double-masked, placebo-controlled Phase IIa study of the AOC3 inhibitor BI 1467335 in diabetic retinopathy.Eye (Lond) 38, no. 10 (July 2024): 1861–69. https://doi.org/10.1038/s41433-024-03017-0.
Dong Nguyen Q, Ehlers JP, Boyer DS, Jin X, Giani A, Ehrlich MS, et al. ROBIN: a randomised, double-masked, placebo-controlled Phase IIa study of the AOC3 inhibitor BI 1467335 in diabetic retinopathy. Eye (Lond). 2024 Jul;38(10):1861–9.
Dong Nguyen, Quan, et al. “ROBIN: a randomised, double-masked, placebo-controlled Phase IIa study of the AOC3 inhibitor BI 1467335 in diabetic retinopathy.Eye (Lond), vol. 38, no. 10, July 2024, pp. 1861–69. Pubmed, doi:10.1038/s41433-024-03017-0.
Dong Nguyen Q, Ehlers JP, Boyer DS, Jin X, Giani A, Ehrlich MS, ROBIN study investigators. ROBIN: a randomised, double-masked, placebo-controlled Phase IIa study of the AOC3 inhibitor BI 1467335 in diabetic retinopathy. Eye (Lond). 2024 Jul;38(10):1861–1869.

Published In

Eye (Lond)

DOI

EISSN

1476-5454

Publication Date

July 2024

Volume

38

Issue

10

Start / End Page

1861 / 1869

Location

England

Related Subject Headings

  • Visual Acuity
  • Treatment Outcome
  • Ophthalmology & Optometry
  • Middle Aged
  • Male
  • Humans
  • Female
  • Double-Blind Method
  • Diabetic Retinopathy
  • Aged