Evidence mapPaperPMID 40750915Full record

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.

Guillermo Salcedo-Villanueva, Gisela Garcia-Sánchez, Claudia Palacio-Pastrana, Gerardo Gascón-Guzmán, Aureliano Moreno-Andrade, Oscar Olvera-Montaño, Patricia Muñoz-Villegas

Registry-linked trialAbstract read
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05217680 phase3completednot on this map

Phase III Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of Intravitreous PRO-169 Compared to Ranibizumab for Diabetic Macular Edema

TypeinterventionalSponsorLaboratorios Sophia S.A de C.V.Ran2021 to 2025Enrolled509ConditionsDiabetic Macular EdemaArmsBevacizumab, Lucentis®
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Guillermo Salcedo-Villanueva *Asociación para Evitar la Ceguera en México, I.A.P., Mexico City, Mexico.
Gisela Garcia-Sánchez *Regional Medical Affairs Department, Laboratorios Sophia, S.A. de C.V., Paseo del Norte 5255, Guadalajara Technology Park, Zapopan, Jalisco, 45010, Mexico.
Claudia Palacio-PastranaSalaUno Salud, S.A.P.I. de C.V., Mexico City, Mexico.
Gerardo Gascón-GuzmánConsultorio de Medicina Especializada, Nuevo Laredo, Tamaulipas, Mexico.
Aureliano Moreno-AndradeRetina Center, Tijuana, Baja California, Mexico.
Oscar Olvera-MontañoRegional Medical Affairs Department, Laboratorios Sophia, S.A. de C.V., Paseo del Norte 5255, Guadalajara Technology Park, Zapopan, Jalisco, 45010, Mexico.
Patricia Muñoz-VillegasRegional Medical Affairs Department, Laboratorios Sophia, S.A. de C.V., Paseo del Norte 5255, Guadalajara Technology Park, Zapopan, Jalisco, 45010, Mexico. patricia.munoz@sophia.com.mx.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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).

Indexed as

anti-VEGFCentral macular thicknessDiabetes mellitusDiabetic macular edemaVisual acuity

Identifiers

PMID40750915
PMCPMC12315349

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.