ArticleInternational journal of retina and vitreous2025
One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population.
Article in International journal of retina and vitreous, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05217680 (Phase III Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of Intravitreous PRO-169 Compared to Ranibizumab for Diabetic Macular Edema), which is not on this map. Cited by 1 paper.
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The trial behind it
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Phase III Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of Intravitreous PRO-169 Compared to Ranibizumab for Diabetic Macular Edema
Who cites it
1 citing paper in PubMed.
- Anti-vascular endothelial growth factor therapy in uveitis: Bridging inflammation and vascular pathology.Indian journal of ophthalmology · 2026Review
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7 authors.
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Abstract
backgroundDiabetic 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.
methodsThis 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.
resultsA 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.
conclusionsThis 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 registrationNCT05217680 (clinicaltrials.gov).
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