A study that uses data from routine eye examinations of patients

Phase 2

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: JPRN-jRCT2080225272
• Lead Sponsor: Bayer Yakuhin, Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-10
• Study Completion: 2020-12-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 287376

Inclusion Criteria

Inclusion Criteria:
Signed informed consent to participate in ReFineDR
Included in FIDELIO or FIGARO, and with DR as medical history
Documented NPDR in at least one eye, as documented by ophthalmological records within 6 months prior to baseline in FIDELIO or FIGARO, and up to one month after baseline in FIDELIO or FIGARO
An ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in FIDELIO or FIGARO, and at least one additional assessment afterwards.

Exclusion Criteria

Exclusion Criteria:
Patients with PDR, macular edema or anterior segment complications present at baseline in FIDELIO or FIGARO in at least one eye.
Patients with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in FIDELIO or FIGARO in at least one eye.
Patients with any other retinal disease documented at baseline in FIDELIO or FIGARO in at least one eye that would likely interfere with the study objectives (e.g. neovascular age-related macular degeneration or retinal vein occlusion).

Study & Design

• Study Type: Observational
• Study Design: Not specified