MERCURY study

Phase 4

Completed

• Conditions: Diabetic Macular Edema (DME)

• Registration Number: JPRN-jRCT1080223554
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

The BCVA improvement in the study is comparable with results from other real-world studies, and is not inferior to that of results from randomized clinical trials. Safety data were consistent with the well-established profile of ranibizumab in the treatment of patients with impaired VA due to DME, with no new safety issues. The psychological results showed that potential positive effects on anxiety were observed with ranibizumab treatment and psychological symptoms for depression didn't worsen.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-07
• Study Completion: 2020-12-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

* DME patients with impaired VA aged 20 years or older.
* Patients to whom ranibizumab treatment is considered as suitable and who are initiating treatment with ranibizumab for the first time.
* Patients not previously treated with any anti-VEGF agents including ranibizumab.
* Patient who is expected to follow visit schedule for at least one year.
* Willing and able to provide written informed consent personally or by a legally acceptable representative(s).

Exclusion Criteria

* Simultaneous participation in a study that includes administration of any investigational drug or procedure.
* Planned to be treated with systemic anti-VEGF agents within at least one year from baseline.
* Patients contraindicated for ranibizumab treatment as per the Japan package insert:
* Patients with a history of hypersensitivity to the ingredients in ranibizumab formulation.
* Patients with infection or patients with suspected infection in and/or around the eye.
* Patients with inflammation in and/or around the eye.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Mean change in BCVA from baseline to 12 months<br>The primary effectiveness variable is the change in BCVA in logMAR from Baseline to 12 months.

Secondary Outcome Measures

Name	Time	Method
efficacy<br>The time course of BCVA change from Baseline in logMAR for 24 months.<br><br>efficacy<br>Center subfield thickness (CSFT)<br><br>other<br>Number of treatment (anti-VEGF agents, combination therapy)<br><br>other<br>Hospital Anxiety and Depression Scale (HADS)<br><br>safety<br>Safety(type, frequency, and severity)