Anti-VEGF combination therapy clinically effective treatment option for nAMD patients

In this study, Participants were randomized to 6, 4-weekly, intravitreal injections of 0.5 mg OPT-302, 2.0 mg OPT-302, or sham, plus intravitreal 0.5 mg ranibizumab. The primary outcome measured in the study was mean change in ETDRS best-corrected visual acuity (BCVA) at 24 weeks.

Secondary outcomes were the proportion of participants gaining or losing ≥ 15 ETDRS BCVA letters; area under the ETDRS BCVA over a time curve; change in spectral-domain OCT (SD-OCT) central subfield thickness; and change in intraretinal fluid and subretinal fluid on SD-OCT.

The findings of the study are:

• Of 366 participants, 122, 123, and 121 were randomized to 0.5 mg OPT-302, 2.0 mg OPT-302, and sham, respectively.
• Mean visual acuity gain in the 2.0 mg OPT-302 group was superior to sham.
• There was no significant difference in the 0.5 mg OPT-302 and the sham group.
• Compared with sham, the secondary BCVA outcomes favoured the 2.0 mg OPT-302 group, with structural outcomes favouring both OPT-302 dosage groups.
• There were similarities in the occurrence of Adverse events (AEs), with 16, 7 and 10 participants in the lower-dose, higher-dose, and sham groups, respectively, developing at least one serious AE.
• In the sham group, two unrelated deaths were reported.

They mentioned, “We observed superior vision gain with OPT-302 2.0 mg combination therapy, versus standard of care, with favourable safety.

The strengths of this study include study design, generalizability of the results, participant compliance, data completeness and statistics.

Improved vision outcomes have significant impacts on a patient’s quality of life in such patients, they said.

Further reading:

https://www.aaojournal.org/article/S0161-6420(23)00066-0/fulltext