FDA Offers Advice on Macular Degeneration Drug Trials

The FDA outlined drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance.

The 8-page draft — which includes recommendations on trial eligibility criteria, efficacy endpoints and trial design considerations — recommends that sponsors consider parallel-group, double-masked trials randomized by patient that aim to show the investigational drug group’s superiority over the control group.

Sponsors can also consider an alternative trial approach that uses the same design but shows the investigational drug’s noninferiority to either ranibizumab injection given intravitreally every four weeks, or to aflibercept given intravitreally either every four weeks or eight weeks (after three monthly injections), the agency says.

The agency is accepting comments on the draft until April 28.

Macular degeneration, also known as age-related macular degeneration (AMD or ARMD), is a medical condition which may result in blurred or no vision in the center of the visual field. Early on there are often no symptoms. Over time, however, some people experience a gradual worsening of vision that may affect one or both eyes. While it does not result in complete blindness, loss of central vision can make it hard to recognize faces, drive, read, or perform other activities of daily life. Visual hallucinations may also occur.

February 28, 2023

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