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Ongoing clinical trials

There are multiple brolucizumab clinical trials currently ongoing in wet AMD and unlicensed indications (diabetic macular edema [DME] and branch and central retinal vein occlusion [BRVO/CRVO]). To keep physicians informed of safety data from these trials we are sharing a snapshot of events of interest.

Masked data from a sample of these ongoing clinical trials is represented below, based on the status of the respective clinical databases as of June 15, 2020. These brolucizumab trials are using aflibercept as the comparator. The actual treatment allocation is still fully masked. These trials are at different stages of advancement. Clinical data is being actively collected and updated in all of these trials.

To represent an approximation of the worst case risk of developing intraocular inflammation (IOI) with retinal vasculitis and/or retinal vascular occlusion, the number of patients randomized to brolucizumab treatment has been estimated and all observed events of interest have been allocated to the estimated brolucizumab population. Based on review of available imaging, the events of interest have been allocated to 1 of 3 categories (no duplication) and the combined risk of at least moderate vision loss at the last available time point has been represented.

Table shows an approximation of the worst case risk when all cases are allocated to the estimated brolucizumab population

MERLIN*
(NCT03710564)

KITE*
(NCT03481660)

KESTREL*
(NCT03481634)

RAPTOR
(NCT03802630)

RAVEN
(NCT03810313)

Indication

wet AMD

DME

DME

BRVO

CRVO

Number of patients randomized

535

360

566

279

258

Estimation of number of patients randomized to brolucizumab

356

180

377

140

129

1) Worst case risk of developing IOI with retinal vasculitis only

5/356 (1.4%)

1/180 (0.6%)

4/377 (1.1%)

0/140 (0.0%)

1/129 (0.8%)

2) Worst case risk of developing IOI with retinal vascular occlusion only

2/356 (0.6%)

1/180 (0.6%)

0/377 (0.0%)

1/140 (0.7%)

1/129 (0.8%)

3) Worst case risk of developing IOI with retinal vasculitis and retinal vascular occlusion

4/356 (1.1%)

2/180 (1.1%)

3/377 (0.8%)

4/140 (2.9%)

3/129 (2.3%)

Combined risk of ≥15 ETDRS letter loss at last available time point

5/356 (1.4%)

2/180 (1.1%)

0/377 (0.0%)

3/140 (2.1%)

1/129 (0.8%)

*Studies fully recruited; Studies still recruiting; Event rates are discrete, there is no duplication between categories

This snapshot of data, from ongoing brolucizumab trials, with allocation of all events of interest to brolucizumab (worst case risk) is in line with the observations from the HAWK and HARRIER trials (wet AMD) as detailed in the Safety Review Committee preliminary report.