STUDY SUBJECTS

• Major inclusion criteria: center-involving DME with central subfield thickness (FTH) of ≥250 µm
• Major exclusion criteria: history of VR surgery, any prior treatment for AMD

RANDOMIZATION SCHEME AND INTERVENTIONS

Randomized (stratified by vision (VA ≤ 20/80; VA > 20/80); lesion subtype; study center) 1:1:1:1 to

(a) ranibizumab 0.5mg monthly

(b) ranibizumab 2mg monthly

(c) ranibizumab 0.5mg monthly x 3 then monthly PRN

(d) ranibizumab 2mg monthly x 3 then monthly PRN

Retreatment criteria for PRN group: monthly evaluation and treatment if ≥ 5 letter decrease in vision or disease activity on OCT (IRF, SRF, sub-RPE fluid)

RESULTS (24 months)

Study population

• 1097 subjects
• Study completion 86%; similar across all groups

Visual acuity end-points

• Loss of < 15 letters: 90-94%, similar across all groups
• Gain of > 15 letter: 33-37%, similar across all groups
• Mean VA change similar in all groups: +9.1 letters (0.5mg monthly), +8.0 (2mg monthly), +7.9 (0.5mg PRN), +7.6 letters (2mg PRN)

# of injections

• At 12 mth: 11.3 (0.5mg monthly), 11.2 (2mg monthly), 7.7 (0.5mg PRN), 6.9 (2mg PRN)
• At 24 mth: 21.4 (0.5mg monthly), 21.6 (2mg monthly), 13.3 (0.5mg PRN), 11.2 (2mg PRN)
• Average treatment interval after the loading doses: 9.9 weeks (0.5mg PRN) and 12.5 weeks (2mg PRN)

Anatomic end-points on OCT

• Mean change in central foveal thickness (CFT) were similar in all groups: -183µm (0.5mg monthly), -172µm (2mg monthly), -172 µm (0.5mg PRN), -181µm (2mg PRN)

Angiographic end-points

• Mean change in total lesion area was similar in all groups: -1.6 disc areas (DA) (0.5mg monthly), -2.1 DA (2mg monthly), -1.1 DA (0.5mg PRN), -1.4 (2mg PRN)

Adverse events

• APTC events were similar in all four groups: 6.6% (0.5mg monthly), 5.8% (2mg monthly), 4.7% (0.5mg PRN), 5.9% (2mg PRN)

CONCLUSIONS

Similar visual and anatomical outcomes in all 4 groups