Our trial centre is participating in the SIENNA trial R3918-AMD-2326. This is a multicentre, randomised, double-blind, placebo-controlled Phase 3 trial investigating the efficacy, safety and tolerability of subcutaneously administered pozelimab in combination with cemdisiran versus cemdisiran monotherapy versus placebo in patients with geographic atrophy resulting from age-related macular degeneration (AMD).

Around 975 participants are to be recruited for the SIENNA trial at approximately 240 trial centres worldwide.

Participants must meet the following eligibility criteria for inclusion in the study:

• Age ≥ 50 to ≤ 85 years
• Study eye with GA, with or without involvement of the foveal centre
• GA ≥ 2.5 mm² and ≤ 17.5 mm²
• GA lesion within 1500 µm of the foveal centre
• Presence of hyperautofluorescence
• GA lesions can be measured separately from areas of peripapillary atrophy
• BCVA ≥ 55 letters (≥ 20/80 = 0.25)
• No current or previous CNV in either eye
• No IVT treatment in either eye within the last 6 months
• No previous surgery on the study eye other than cataract or glaucoma surgery
• No use of systemic corticosteroids within the last 30 days
• No hospitalisation due to an infection within the last 3 years

Study protocol:

The SIENNA study will last approximately 154 weeks (with the option of an additional 3-year extension period) and will comprise the following:

A screening period comprising 2–3 screening appointments within approximately 3 months prior to the first administration of the medication
A 24-month study period with monthly subcutaneous injections of the investigational drug (pozelimab in combination with cemdisiran versus cemdisiran monotherapy versus placebo in a 1:1:1 ratio)
This will be followed by a 36-week follow-up period or, if desired, enrolment in the 3-year extension period, during which patients who previously received a sham treatment will receive Pozelimab + Cemdisiran or Cemdisiran monotherapy.

If you have any questions about the project or know of a suitable candidate, please do not hesitate to contact us at the trial centre.