STUDY SUBJECTS

Major inclusion criteria:

• active fovea-involving CMV from AMD

Major exclusion criteria:

• prior participation in an AMD trial
• >3 prior PDT treatments, any prior laser within 1 month
• subfoveal fibrosis or atrophy

STUDY INTERVENTIONS

Ranibizumab 0.5mg monthly x 3, then monthly PRN any of the following:

• persistent fluid 1 month after the prior injection
• VA loss of ≥ 5 letters
• central retinal thickness (CRT) increase of ≥ 100 µm
• new macular hemorrhage
• new area of classic CNVM

After the monthly treatment period, exam and OCT performed monthly and FA was performed q3 months

Amendment: In year 2, retreatment for any qualitative change on OCT suggestive of recurrent fluid (IRF, SRF, but also enlargement of PED)

Note: a subset of patients initially mistakenly received ranibizumab 0.3mg

RESULTS (24 months)

Study population

• 40 patients
• Study completion was >90%

Visual acuity end-points

• Mean visual acuity +11.1 letters relative to baseline
• 43% gained ≥ 15 letters
• 3% lost ≥ 15 letters

Anatomical outcomes

• Significant decrease in CRT on OCT

Treatment

• Mean 9.9 injections over 2 years

CONCLUSIONS

• OCT-guided variable dosing achieved similar visual outcomes as monthly trials, with fewer injections