Biological Sciences Division
Published April 15, 2024 | Version v1
Journal article Open

Aqueous humour interleukin-6 and vision outcomes with anti-vascular endothelial growth factor therapy

Creators

  • 1. Stanford University
  • 2. Roche Pharma Research and Early Development
  • 3. Genentech Inc.
  • 4. University of Chicago

Description

Background: This analysis evaluated aqueous humour (AH) interleukin (IL)-6 concentrations and the association between AH IL-6 and visual outcomes in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DMO) receiving anti-vascular endothelial growth factor (VEGF) monotherapy.

Methods: Post hoc analysis of the multicentre, double-masked, randomised HARBOR (NCT00891735) and READ-3 (NCT01077401) trials. HARBOR enrolled treatment-naïve nAMD patients. READ-3 enrolled treatment-naïve/previously treated DMO patients. HARBOR patients received ranibizumab 0.5 or 2.0 mg monthly or as needed; AH samples were collected at month 2, after two previous intravitreal injections. READ-3 patients received ranibizumab 0.5 or 2.0 mg as needed; AH samples were collected at baseline and months 3, 6, 9, and 12.

Main outcome measure: association between AH IL-6 concentrations and month 24 best-corrected visual acuity (BCVA).

Results: In both trials (HARBOR, N = 36; READ-3, N = 137), patients with higher AH IL-6 concentrations had worse visual outcomes. HARBOR patients with low AH IL-6 concentrations at month 2 had a mean (95% CI) BCVA change at month 24 of +2.9 (-2.6, 8.3) letters, whereas patients with high AH concentrations had a mean (95% CI) BCVA change of -9.0 (-22.7, 4.7) letters. READ-3 patients with low AH concentrations at baseline had a mean (95% CI) BCVA change at month 12 of +9.3 (7.4, 11.3) letters, whereas patients with high AH concentrations had a mean (95% CI) BCVA change of +5.6 (2.2, 9.1) letters.

Conclusions: Higher IL-6 AH concentrations may predict suboptimal visual responses to anti-VEGF monotherapy in patients with nAMD/DMO.

Data availability

For HARBOR, qualified researchers may request access to individual patient-level clinical data through a data request platform. At the time of writing, this request platform is Vivli (https://vivli.org/ourmember/roche/). For up-to-date details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: https://go.roche.com/data_sharing. Anonymised records for individual patients across more than 1 data source external to Roche cannot, and should not, be linked due to a potential increase in risk of patient re-identification.

Files

Aqueous-humour-interleukin-6-and-vision-outcomes-with-anti-vascular-endothelial-growth-factor-therapy.pdf

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Additional details

Identifiers

DOI
10.1038/s41433-024-03015-2
Other
oai:uchicago.tind.io:11555

Funding

Genentech, Inc.
Juvenile Diabetes Research Foundation

UChicago Information

Division(s)
Biological Sciences Division
Department(s)
Ophthalmology and Visual Science