Trial reportDiabetes care2010
Infliximab for diabetic macular edema refractory to laser photocoagulation: a randomized, double-blind, placebo-controlled, crossover, 32-week study.
Trial report in Diabetes care, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
47 citing papers in PubMed, 104 citations in OpenAlex.
- Ocular drug delivery systems based on nanotechnology: a comprehensive review for the treatment of eye diseases.Discover nano · 2025Review
- Interferon alpha-2b addition to intravitreal bevacizumab for diabetic macular edema: a randomized controlled trial.International journal of retina and vitreous · 2025Article
- Lipoxin A4 (LXA4) as a Potential Drug for Diabetic Retinopathy.Medicina (Kaunas, Lithuania) · 2025Review
- Antibody-based therapeutics and therapeutic development for diabetic retinopathy: targeting VEGF, Ang/Tie, and inflammatory pathways.Frontiers in endocrinology · 2025Review
- Immune cell contribution to vascular complications in diabetes.Frontiers in endocrinology · 2025Review
- Elevated aqueous TNF-α levels are associated with more severe functional and anatomic findings in eyes with diabetic macular oedema.Clinical & experimental ophthalmology · 2024Article
- Incidence of diabetic retinopathy in anti-tnf treated rheumatic disease patients with type 2 diabetes.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024Article
- Diabetic macular edema (DME): dissecting pathogenesis, prognostication, diagnostic modalities along with current and futuristic therapeutic insights.International journal of retina and vitreous · 2024Review
- The role of microglia in the development of diabetic retinopathy.npj metabolic health and disease · 2024Review
- Aldose Reductase as a Key Target in the Prevention and Treatment of Diabetic Retinopathy: A Comprehensive Review.Biomedicines · 2024Review
- Disentangling the association between retinal non-perfusion and anti-VEGF agents in diabetic retinopathy.Eye (London, England) · 2022Review
- Targeting Microglia to Treat Degenerative Eye Diseases.Frontiers in immunology · 2022Review
- Neuroinflammation and neurodegeneration in diabetic retinopathy.Frontiers in aging neuroscience · 2022Review
- Inflammatory mediators in diabetic retinopathy: Deriving clinicopathological correlations for potential targeted therapy.Indian journal of ophthalmology · 2021Review
- The innate immune system in diabetic retinopathy.Progress in retinal and eye research · 2021Review
- Recent Advancements in the Medical Treatment of Diabetic Retinal Disease.International journal of molecular sciences · 2021Review
- Pericytes, inflammation, and diabetic retinopathy.Inflammopharmacology · 2020Review
- Synthesis and structure-activity relationships of thieno[2,3-d]pyrimidines as atypical protein kinase C inhibitors to control retinal vascular permeability and cytokine-induced edema.Bioorganic & medicinal chemistry · 2020Article
- The Evolving Treatment of Diabetic Retinopathy.Clinical ophthalmology (Auckland, N.Z.) · 2020Review
- The role of inflammation in diabetic eye disease.Seminars in immunopathology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveBecause many patients with diabetic macular edema (DME) do not respond to focal/grid laser photocoagulation, the only currently approved treatment, alternatives are needed. Based on encouraging preliminary findings, we aimed to assess efficacy and safety of the anti-tumor necrosis factor (TNF) monoclonal antibody infliximab in this condition. RESEARCH DESIGN AND
methodsThis was a single-center, double-blind, randomized, placebo-controlled, crossover study. Eleven patients with sight-threatening DME persisting after two sessions of laser photocoagulation received infliximab (5 mg/kg) intravenously at weeks 0, 2, 6, and 14, followed by placebo at weeks 16, 18, 22, and 30, or vice versa. Blinding was maintained to week 32, when the final assessments were performed. Best corrected visual acuity evaluated by a mixed-models approach for imbalanced crossover design using the percentage difference as the outcome variable was the primary study end point. Data were analyzed on an intention-to-treat basis.
resultsEarly Treatment of Diabetic Retinopathy Study (ETDRS) scores dropped from 31.6 +/- 5.1 (mean +/- SD) letters read at baseline to 28.8 +/- 11.6 letters read at week 16 in six placebo-treated eyes and improved to 35.4 +/- 11.2 letters read after infliximab. In contrast, visual acuity improved from 23.5 +/- 10.3 at baseline to 30.4 +/- 13.4 letters read at week 16 in eight infliximab-treated eyes and was sustained at completion of placebo treatment (31.4 +/- 12.1 letters read). The excess visual acuity in infliximab-treated eyes was greater by 24.3% compared with that in placebo-treated eyes (95% CI 4.8-43.7; P = 0.017). Infliximab treatment was well tolerated.
conclusionsThe positive results of this small phase III study suggest that larger and longer term trials should be conducted to assess the efficacy of systemic or intravitreal anti-TNF agent administration for primary treatment of DME.
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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 OpenQuestion graph.