VOYAGER Study

JRCT ID: jRCT1031220434

Registered date:04/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
• Date of first enrollment: 21/11/2022
• Target sample size: 5000
• Countries of recruitment: USA,Japan,Australia,Japan,Canada,Japan,Chile,Japan,Czech Republic,Japan,Denmark,Japan,Egypt,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Norway,Japan,Poland,Japan,Saudi Arabia,Japan,Singapore,Japan,Slovenia,Japan,South Korea,Japan,Sweden,Japan,Switzerland,Japan,Thailand,Japan,Turkey,Japan,United Arab Emirates,Japan,United Kingdom,Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Change in VA (approximate ETDRS letter score) from baseline at month 12, per eye, per approved retinal indication and per Roche product.

Secondary Outcome

- Change in VA (approximate ETDRS letter score) from baseline at months 3, 6, 24 and annually thereafter, per eye, per approved retinal indication and per Roche product.
- Number and percentage of eyes in each treatment regimen (i.e., Fixed regimen, T and E, PRN, Other), per approved retinal indication and per product.
- Number and percentage of treatments, per year, per approved retinal indication and per product.
- Time spent on each treatment, overall and per regimen (i.e., Fixed regimen, T and E, PRN, Other), per eye, per approved retinal indication and per product.
- Number and percentage of eyes with treatment switch and number and percentage of eyes with treatment regimen switch, and reason for switch, at 3, 6, 12 months and annually thereafter, per approved retinal indication and per product.
- Total number of visits, number of visits with or without treatment, and time interval between treatments, per year, per approved retinal indication and per product.
- Number, type, and frequency of ocular concomitant and subsequent medications received during the study period, per approved retinal indication and per product.
- Change in VA (approximate ETDRS letter score) from baseline at months 3, 6, 12 and annually thereafter, per eye, per approved retinal indication, and per Roche product, according to the:
- Treatment regimen (Fixed, T and E, PRN, Other)
- Number of treatments
- Total number of visits
- Treatment schedule
- Incidence, severity, duration, and outcome of ocular and non-ocular adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Have provided informed consent, as required per local regulations
-Adult patients, as defined by local regulations and local product label, who are being treated with any approved Roche ophthalmology product in retinal indication in scope for this study, according to the investigator's discretion in routine clinical practice (irrespective of whether the patient is starting treatment at the time of enrollment or is already receiving treatment). Patients are also considered eligible if they are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication in scope for this study

• Exclude criteria: Concomitant participation in an investigational ophthalmology clinical trial that includes receipt of any investigational drug or procedure within the last 28 days prior to enrollment (this restriction does not apply to patients who are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication in scope for this study)

Related Information

• Primary Sponsor: Tsujimura Jun
• Secondary ID(s): NCT05476926