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Topical bevacizumab in the treatment of corneal neovascularization: results of a prospective, open-label, noncomparative study.

ABSTRACT: To study the safety and efficacy of topical bevacizumab in the treatment of corneal neovascularization (NV).In a prospective, open-label, noncomparative study, 10 eyes from 10 patients with stable corneal NV were treated with topical bevacizumab, 1.0%, for 3 weeks and followed up for up to 24 weeks.The primary safety variables were the occurrence of ocular and systemic adverse events throughout the course of the study. The primary efficacy variables were neovascular area, the area of the corneal vessels themselves; vessel caliber, the mean diameter of the corneal vessels; and invasion area, the fraction of the total corneal area covered by the vessels.From baseline visit to the last follow-up visit, mean reductions were 47.1% (standard deviation [SD], 36.7%) for neovascular area, 54.1% (SD, 28.1%) for vessel caliber, and 12.2% (SD, 42.0%) for invasion area. The decreases in neovascular area and vessel caliber were statistically significant (P= .001 and P< .001, respectively). However, changes in invasion area did not achieve statistical significance (P= .19). Visual acuity and central corneal thickness showed no significant changes. Topical bevacizumab was well tolerated with no adverse events.Short-term topical bevacizumab therapy reduces the severity of corneal NV without local or systemic adverse effects.Topical bevacizumab provides an alternative therapy in the treatment of stable corneal NV.clinicaltrials.gov Identifier: NCT00559936.

SUBMITTER: Dastjerdi MH

PROVIDER: S-EPMC2703579 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature

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Topical bevacizumab in the treatment of corneal neovascularization: results of a prospective, open-label, noncomparative study.

Dastjerdi Mohammad H MH Al-Arfaj Khalid M KM Nallasamy Nambi N Hamrah Pedram P Jurkunas Ula V UV Pineda Roberto R Pavan-Langston Deborah D Dana Reza R

Archives of ophthalmology (Chicago, Ill. : 1960) 20090401 4

<h4>Objective</h4>To study the safety and efficacy of topical bevacizumab in the treatment of corneal neovascularization (NV).<h4>Design</h4>In a prospective, open-label, noncomparative study, 10 eyes from 10 patients with stable corneal NV were treated with topical bevacizumab, 1.0%, for 3 weeks and followed up for up to 24 weeks.<h4>Main outcome measures</h4>The primary safety variables were the occurrence of ocular and systemic adverse events throughout the course of the study. The primary ef ...[more]

PMID: 19365012

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Project description:PurposeBreast cancer-related lymphedema (BCRL) is a chronic, progressive side effect of breast cancer treatment, occurring in one-third of patients treated with axillary lymph node dissection and nodal radiotherapy. Cluster of differentiation 4-positive (CD4+) cells plays a key role in BCRL by facilitating inflammation and inhibiting lymphangiogenesis. Tacrolimus is an anti-inflammatory and immunosuppressive macrolide that targets CD4+ cells. Treatment of lymphedema with topical tacrolimus has revealed promising results in preclinical trials. This clinical trial was aimed at evaluating the feasibility, safety, and effect of tacrolimus in women with stage I or II BCRL, according to the International Society of Lymphology.MethodsWe conducted this open-label, single-arm, phase II pilot trial from September 2020 to April 2021. Eighteen women with BCRL stage I or II BCRL were treated with topical tacrolimus for 6 months and followed up at 3 and 6 months. The primary outcome was arm volume, and secondary outcomes were the lymphedema index (L-Dex), health-related quality of life (HRQoL), lymph flow and function, and safety and feasibility of the trial design.ResultsThe mean lymphedema arm volume and L-Dex reduced significantly by 130.44 ± 210.13 mL (p < 0.05; relative reduction: 3.6%) and 3.54 ± 4.98 (p < 0.05), respectively, and health-related quality of life scores was improved significantly (p < 0.05). According to the MD Anderson scale, in terms of lymph flow and function, three patients (16.7%) showed improvement, while none showed worsening. Lymph flow or function showed no change according to the Arm Dermal Backflow scale.ConclusionIn this trial, treatment with tacrolimus was safe and feasible in women with stage I or II BCRL. Tacrolimus alleviated BCRL in terms of improved arm volume, L-Dex, and HRQoL. Assessments of lymph flow and function were positive, although inconclusive. Larger randomized controlled trials are required to verify these findings.Trial registrationClinicalTrials.gov Identifier: NCT04541290.

Dataset Information

Topical bevacizumab in the treatment of corneal neovascularization: results of a prospective, open-label, noncomparative study.

Publications

Topical bevacizumab in the treatment of corneal neovascularization: results of a prospective, open-label, noncomparative study.

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