One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population
Abstract 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...
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| Format: | Article |
| Language: | English |
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BMC
2025-08-01
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| Series: | International Journal of Retina and Vitreous |
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| Online Access: | https://doi.org/10.1186/s40942-025-00719-9 |
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| author | Guillermo Salcedo-Villanueva Gisela Garcia-Sánchez Claudia Palacio-Pastrana Gerardo Gascón-Guzmán Aureliano Moreno-Andrade Oscar Olvera-Montaño Patricia Muñoz-Villegas |
| author_facet | Guillermo Salcedo-Villanueva Gisela Garcia-Sánchez Claudia Palacio-Pastrana Gerardo Gascón-Guzmán Aureliano Moreno-Andrade Oscar Olvera-Montaño Patricia Muñoz-Villegas |
| author_sort | Guillermo Salcedo-Villanueva |
| collection | DOAJ |
| description | Abstract 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). |
| format | Article |
| id | doaj-art-446c8e790aeb4887bfc535c0c7a41cff |
| institution | Kabale University |
| issn | 2056-9920 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
| series | International Journal of Retina and Vitreous |
| spelling | doaj-art-446c8e790aeb4887bfc535c0c7a41cff2025-08-20T03:46:21ZengBMCInternational Journal of Retina and Vitreous2056-99202025-08-0111111210.1186/s40942-025-00719-9One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino populationGuillermo Salcedo-Villanueva0Gisela Garcia-Sánchez1Claudia Palacio-Pastrana2Gerardo Gascón-Guzmán3Aureliano Moreno-Andrade4Oscar Olvera-Montaño5Patricia Muñoz-Villegas6Asociación para Evitar la Ceguera en México, I.A.P.Regional Medical Affairs Department, Laboratorios Sophia, S.A. de C.V.SalaUno Salud, S.A.P.I. de C.V.Consultorio de Medicina EspecializadaRetina CenterRegional Medical Affairs Department, Laboratorios Sophia, S.A. de C.V.Regional Medical Affairs Department, Laboratorios Sophia, S.A. de C.V.Abstract 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).https://doi.org/10.1186/s40942-025-00719-9Central macular thicknessDiabetes mellitusDiabetic macular edemaVisual acuityanti-VEGF |
| spellingShingle | Guillermo Salcedo-Villanueva Gisela Garcia-Sánchez Claudia Palacio-Pastrana Gerardo Gascón-Guzmán Aureliano Moreno-Andrade Oscar Olvera-Montaño Patricia Muñoz-Villegas One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population International Journal of Retina and Vitreous Central macular thickness Diabetes mellitus Diabetic macular edema Visual acuity anti-VEGF |
| title | One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population |
| title_full | One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population |
| title_fullStr | One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population |
| title_full_unstemmed | One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population |
| title_short | One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population |
| title_sort | one year results of visual response following intravitreal novel anti vegf injection for diabetic macular edema in a latino population |
| topic | Central macular thickness Diabetes mellitus Diabetic macular edema Visual acuity anti-VEGF |
| url | https://doi.org/10.1186/s40942-025-00719-9 |
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