Losartan for Corneal Fibrosis

Официальное название

Topical Losartan as Treatment to Reduce Corneal Scarring Fibrosis

Обзор

This is a prospective, randomized, double-blinded, controlled clinical trial designed to evaluate the efficacy and safety of topical losartan in improving visual acuity, contrast sensitivity and reducing corneal densitometry, corneal aberrations and corneal scarring severity in adult patients with corneal scars of different etiologies. Participants will be randomly assigned to receive either topical losartan 0.8 mg/mL or placebo eyedrops 6 times per day for six months.

Подробное описание

Corneal scarring is a significant cause of visual impairment worldwide, with limited conservative treatment options. Corticosteroids are commonly used but are associated with important adverse effects. Losartan, an angiotensin II receptor blocker, has demonstrated antifibrotic effects through inhibition of TGF-β signaling in experimental studies.

This study aims to evaluate the safety and efficacy of topical losartan in improving visual function and corneal transparency in patients with corneal scarring fibrosis. Outcomes include changes in best-corrected visual acuity measured using the ETDRS chart, contrast sensitivity with FACT chart, corneal scar area calculated with ImageJ, corneal density assessed by Scheimpflug corneal densitometry, corneal aberrations using Zernike Analysis and clinical corneal scar severity evaluated using slit-lamp biomicroscopy with Fantes haze grading, compared with placebo. A total of 46 adult patients with stable corneal scars will be enrolled and followed for six months.

Вмешательства

• Препарат Topical losartan
  Drug: Topical Losartan 0.8 mg/ml ophthalmic solution, one drop applied six times daily for six months.
• Препарат Placebo Control
  Drug: Balanced saline solution ophthalmic drops, one drop applied six times daily for six months.

Первичные конечные точки

• Change in Best Corrected Visual Acuity (BCVA) [Срок оценки: Baseline to 6 months.]

Вторичные конечные точки (10)

• Change in Contrast Sensitivity [Срок оценки: Baseline to 6 months.]
• Change in Corneal Haze Severity [Срок оценки: Baseline to 6 months.]
• Change in Corneal Scar Density [Срок оценки: Baseline to 6 months]
• Change in Corneal Scar Area [Срок оценки: Baseline to 6 months.]
• Change in corneal aberrations [Срок оценки: Baseline to 6 months.]
• Change in Intraocular Pressure [Срок оценки: Baseline to 6 months.]
• Change in corneal pachymetry [Срок оценки: Baseline to 6 months.]
• Corneal scar depth [Срок оценки: Baseline to 6 months.]
• Treatment Adverse Events [Срок оценки: Baseline to 6 months.]
• Treatment Adherence [Срок оценки: Baseline to 6 months.]

Критерии участия

• Inclusion Criteria:

• Adults aged 18 years or older
• Presence of corneal scar with a duration of at least 1 month
• Corneal scars of any etiology
• Corneal scars with or without corneal neovascularization
• Stable corneal scar without epithelial defect
• No active treatment for the underlying condition for at least 1 month
• Exclusion Criteria:

• Refusal or inability to provide written informed consent
• Presence of corneal epithelial defect or friable epithelium
• Age under 18 years
• Pregnancy
• Known allergy or hypersensitivity to losartan

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Ophthalmology Department — Monterrey

Публикации

• COZAAR® (losartan potassium) tablets, for oral use Initial U.S. Approval: 1995 . FDA
• PLM. (n.d.). COZAAR - Comprimidos. Medicamentos PLM. Recuperado el 9 de febrero de 2025, de https://www.medicamentosplm.com/Home/productos/cozaar.comprimidos/128/101/77344/25
• Mauer M, Zinman B, Gardiner R, Suissa S, Sinaiko A, Strand T, Drummond K, Donnelly S, Goodyer P, Gubler MC, Klein R. Renal and retinal effects of enalapril and losartan in type 1 diabetes. N Engl J Med. 2009 Jul 2;361(1):40-51. doi: 10.1056/NEJMoa0808400. PMID 19571282
• Burnier M, Waeber B, Brunner HR. Clinical pharmacology of the angiotensin II receptor antagonist losartan potassium in healthy subjects. J Hypertens Suppl. 1995 Jul;13(1):S23-8. doi: 10.1097/00004872-199507001-00003. PMID 18800452
• Zandbergen AA, Baggen MG, Lamberts SW, Bootsma AH, de Zeeuw D, Ouwendijk RJ. Effect of losartan on microalbuminuria in normotensive patients with type 2 diabetes mellitus. A randomized clinical trial. Ann Intern Med. 2003 Jul 15;139(2):90-6. doi: 10.7326/0003-4819-139-2-200307150-00008. PMID 12859158
• Kubba S, Agarwal SK, Prakash A, Puri V, Babbar R, Anuradha S. Effect of losartan on albuminuria, peripheral and autonomic neuropathy in normotensive microalbuminuric type 2 diabetics. Neurol India. 2003 Sep;51(3):355-8. PMID 14652437
• 45. Pucker AD, Frogozo M, Malooley MM, Harthan JS. Point-Counter Point: Treating Corneal Haze with 0.8 mg/mL Topical Losartan. Clinical Insights in Eyecare. 2024;2(5).
• Rodgers EG, Al-Mohtaseb Z, Chen AJ. Topical Losartan for Treating Corneal Haze After Ultraviolet-A/Riboflavin Collagen Cross-Linking. Cornea. 2024 Sep 1;43(9):1165-1170. doi: 10.1097/ICO.0000000000003527. Epub 2024 Mar 22. PMID 38573840

Идентификаторы

NCT: NCT07449000 · OF25-00010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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