One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population.

Background: Diabetic macular edema (DME) is a leading cause of vision impairment. This study evaluated the effects of multiple anti-VEGF intravitreal injections, including a novel anti-VEGF PRO-169, on best-corrected visual acuity (BCVA) and central macular thickness (CMT) in Latino patients with DME.

Methods: This is a multicenter, drug-agnostic interim analysis. Patients were randomized 1:1 to receive monthly injections for four months after a pro re nata intravitreal injection of either PRO-169 or ranibizumab over a one-year period.

Results: A total of 278 eyes with DME were analyzed. The average age of the participants was 62.1 ± 7.4 years, with diabetes diagnosed at an average of 16.7 ± 8.4 years and DME detected 1.2 ± 1.6 years later. By week 48, patients with an initial BCVA letter score of < 69 experienced a gain of 13.1 ± 10.4 letters, with an injection frequency of 34.5 ± 6.9 days per injection. The group showed a reduction in CMT of -127 ± 153 μm, compared to a -82.2 ± 82.1 μm reduction in those with an initial BCVA between 69 and 78 letters (p = 0.016). Additionally, 49% of patients with an initial score < 69 letters improved their visual acuity to 20/40 or better, and 41.5% gained 15 or more letters.

Conclusions: This interim analysis indicates the potential effectiveness of the anti-VEGF agents PRO-169 and ranibizumab, especially for patients with initial visual acuity < 69 letters. The final analysis will be essential for verifying the efficacy and safety of PRO-169. This study provides solid evidence to support ophthalmologists treating Latino patients with DME and likely improves patient care.

Trial registration: NCT05217680 (clinicaltrials.gov).