Study identification

PURI

https://redirect.ema.europa.eu/resource/35754

EU PAS number

EUPAS8816

Study ID

35754

Official title and acronym

A 36 month observational study to describe the long-term efficacy and safety of ranibizumab 0.5 mg treatment in patients with visual impairment due to choroidalneovascularization (CNV) secondary to pathologic myopia (PM)

DARWIN EU® study

No

Study countries

Canada
Egypt
France
Germany
Italy
Poland
Portugal
Russian Federation
Spain
Switzerland
United Kingdom

Study description

This is a 36-month, 300-patient observational study to describe the long-term efficacy and safety of ranibizumab in patients with visual impairment due to CNV secondary to PM treated according to local regulations and standards of clinical practice. This study is a voluntary PASS.Patients with previous or concomitant treatment with verteporfin-PDT or previous laser are eligible for enrollment. Enrolled patients should not have received treatment with a systemic VEGF inhibitor for 90 days prior to enrollment, or an ocular VEGF inhibitor for 30 days prior to enrollment.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 80 centres are involved in the study

Contact details

Clinical Disclosure Office

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma, AG
Study protocol
Initial protocol

RFB002F2401-v00-protocol redacted

English (2.13 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable