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 moderate to severe non-proliferative diabetic retinopathy

Conditions

Diabetic retinopathy

Brief summary

The primary endpoint is the occurrence of a ≥2 step improvement compared with baseline in DRSS level in the study eye at Week 52 as assessed by UWF-CFP images (within the 7-field grid).

Detailed description

The key secondary endpoint is the occurrence of VTCs, defined as PDR and/or anterior segment NV, or development of CI-DME, in the study eye between baseline and Week 52, Absolute change from baseline of BCVA [ETDRS letters] in the study eye at Week 52, Absolute change from baseline of central subfield thickness (CST) [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52, Occurrence of a ≥2 step worsening of DRSS in the study eye between baseline and Week 52 as assessed by UWF-CFP images (within the 7-field grid), Occurrence of PDR and/or anterior segment NV in the study eye between baseline and Week 52, Occurrence of CI-DME in the study eye between baseline and Week 52, Occurrence of drug-related AEs between baseline and EOS, Occurrence of ocular AEs in the study eye between baseline and EOS, Occurrence of ocular AEs of special interest in the study eye between baseline and EOS

Related papers

No related papers found yet.

Interventions

DRUGBI 764524

DRUGSham Injection Procedure

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the occurrence of a ≥2 step improvement compared with baseline in DRSS level in the study eye at Week 52 as assessed by UWF-CFP images (within the 7-field grid).	—

Secondary

Measure	Time frame
The key secondary endpoint is the occurrence of VTCs, defined as PDR and/or anterior segment NV, or development of CI-DME, in the study eye between baseline and Week 52, Absolute change from baseline of BCVA [ETDRS letters] in the study eye at Week 52, Absolute change from baseline of central subfield thickness (CST) [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52, Occurrence of a ≥2 step worsening of DRSS in the study eye between baseline and Week 52 as assessed by UWF-CFP images (within the 7-field grid), Occurrence of PDR and/or anterior segment NV in the study eye between baseline and Week 52, Occurrence of CI-DME in the study eye between baseline and Week 52, Occurrence of drug-related AEs between baseline and EOS, Occurrence of ocular AEs in the study eye between baseline and EOS, Occurrence of ocular AEs of special interest in the study eye between baseline and EOS	—

Measure

Time frame

The key secondary endpoint is the occurrence of VTCs, defined as PDR and/or anterior segment NV, or development of CI-DME, in the study eye between baseline and Week 52, Absolute change from baseline of BCVA [ETDRS letters] in the study eye at Week 52, Absolute change from baseline of central subfield thickness (CST) [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52, Occurrence of a ≥2 step worsening of DRSS in the study eye between baseline and Week 52 as assessed by UWF-CFP images (within the 7-field grid), Occurrence of PDR and/or anterior segment NV in the study eye between baseline and Week 52, Occurrence of CI-DME in the study eye between baseline and Week 52, Occurrence of drug-related AEs between baseline and EOS, Occurrence of ocular AEs in the study eye between baseline and EOS, Occurrence of ocular AEs of special interest in the study eye between baseline and EOS

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Countries

Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed