Study identification

PURI

https://redirect.ema.europa.eu/resource/48496

EU PAS number

EUPAS34826

Study ID

48496

Official title and acronym

Incidence of Central Retinal Artery Occlusion in the Neovascular Age-related Macular Degeneration Population (RAO in neovascular AMD)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

There is concern over increased risk of central Retinal Artery Occlusion (cRAO) following exposure to intravitreal aflibercept for which neovascular (wet) age-related macular degeneration (nAMD) is the principal indication. There is a marked paucity of published data describing the incidence of cRAO in the general population. A request has been made for additional data on the incidence of RAO in the nAMD population to support the regulatory decision-making process. The aims of this study are: (i) To establish the incidence of recorded cRAO in the general (IMRD-UK) population stratified by age, sex and smoking status, (ii) To compare the incidence of recorded cRAO rate between IMRD-UK and existing published studies, (iii) To describe the demographic makeup of the population with recorded nAMD in IMRD-UK by age, sex and smoking status, (iv) To derive an estimate of the incidence of recorded cRAO (and any RAO) standardised to the recorded nAMD population (stratified by both age & sex AND age, sex & smoking status), and, (v) To describe the actual incidence of recorded cRAO (and any RAO) in the nAMD population (accepting that numbers will be very low with both the underlying condition and outcome of interest being relatively rare).

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Robert Flynn

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Internal funding
Study protocol
Initial protocol

Protocol RAO in AMD

English (267.69 KB - 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