CRIMSON

• Research type

  Research Study

• Full title

  CRIMSON: A multicentre, randomised, sham-controlled (and active controlled in the USA), double-masked, 72-week trial to study the safety, tolerability, pharmacokinetics, and efficacy of 3 dosing regimens of intravitreal BI 764524 in patients with moderately severe to severe non-proliferative diabetic retinopathy

• IRAS ID

  1010101

• Contact name

  CT Disclosure & Data Transparency (functional contact point)

• Contact email

  clintriage.rdg@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim Pharma GmbH & Co. KG

• Clinicaltrials.gov Identifier

  NCT06321302

• Research summary

  The purpose of this study is to find out whether BI 764524 helps people with diabetic retinopathy. High blood sugar can damage the small blood vessels in the eyes leading to diabetic retinopathy and vision loss. Treatment starts only at a later stage of the disease. At the later stage people may already have proliferative diabetic retinopathy or diabetic macular oedema. There is a high need for improved and earlier treatment options to prevent vision loss because the number of people with diabetes is increasing worldwide.
  The goal of this study is to find out which BI 764524 treatment plan helps people with non-proliferative diabetic retinopathy. Participants get BI 764524 injected into the eye and the study aims to minimize the number of injections. After 1 year of treatment, the proportions of participants with eye improvements (less severe eye damage and less complications) are compared with study start. To find out whether the improvement was caused by BI 764524 treatment, the effect is also compared with a sham control group where participants experience a procedure like an injection into the eye but without the use of a needle.
  Participants are put into 4 groups by chance. Participants in groups 1, 2, and 3 get BI 764524. Participants in group 4 only get a sham control. Only in the USA, participants are put into 5 groups. Participants in group 5 get aflibercept. Aflibercept is a medicine already used to treat diabetic retinopathy.
  Approximately 175 participants are expected to take part in 80 study sites in 10 countries.
  The Sponsor of this study is Boehringer Ingelheim Pharma GmbH & Co. KG.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  24/LO/0487

• Date of REC Opinion

  1 Aug 2024

• REC opinion

  Further Information Favourable Opinion