Document Detail


Topical mecamylamine for diabetic macular edema.
MedLine Citation:
PMID:  20189159     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: Stimulation of nicotinic acetylcholine (nACh) receptors on vascular endothelial cells promotes angiogenesis and vascular permeability in animal models. The safety and bioactivity of topical mecamylamine, an antagonist of nACh receptors, was tested in patients with diabetic macular edema.
DESIGN: A multicenter phase I/II clinical trial.
METHODS: Twenty-three patients with chronic diabetic macular edema received 1% mecamylamine topically twice daily for 12 weeks, the primary end point. Patients underwent safety assessments, measurement of best-corrected visual acuity (BCVA), and measurement of foveal thickness using optical coherence tomography at baseline, 1, 4, 8, 12, and 16 weeks.
RESULTS: Mecamylamine drops were well tolerated and there were no drug-related safety problems. Mean improvement in BCVA at 1, 4, 8, 12, and 16 weeks was 2.8, 1.9, 2.4, 0.8, and 3.1 letters, respectively. There was little change in mean excess foveal thickness. There was substantial heterogeneity in response, because 8 patients showed convincing improvement in BCVA, foveal thickness, or both, 9 patients showed equivocal or no substantial changes, and 4 patients showed worsening. Five patients showed a substantial improvement in BCVA, foveal thickness, or both between their last visit while receiving mecamylamine and 1 month after stopping mecamylamine.
CONCLUSIONS: This study suggested that administration of topical mecamylamine, a nonspecific nACh receptor blocker, may have heterogeneous effects in patients with diabetic macular edema. Variable expression of nACh receptor subtypes on endothelial cells that have different effects on permeability would provide an explanation for these results and should be investigated, because more specific nACh receptor blockers may dissociate antipermeability and propermeability effects.
Authors:
Peter A Campochiaro; Syed Mahmood Shah; Gulnar Hafiz; Jeffery S Heier; Eugene S Lit; Ingrid Zimmer-Galler; Roomasa Channa; Quan Dong Nguyen; Beena Syed; Diana V Do; Lili Lu; James Monk; John P Cooke; M Ken Kengatharan; Henry H Hsu
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2010-02-26
Journal Detail:
Title:  American journal of ophthalmology     Volume:  149     ISSN:  1879-1891     ISO Abbreviation:  Am. J. Ophthalmol.     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-04-19     Completed Date:  2010-05-06     Revised Date:  2013-05-30    
Medline Journal Info:
Nlm Unique ID:  0370500     Medline TA:  Am J Ophthalmol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  839-51.e1     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 Elsevier Inc. All rights reserved.
Affiliation:
Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-9277, USA. pcampo@jhmi.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00536692
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Adolescent
Adult
Aqueous Humor / metabolism
Chronic Disease
Diabetic Retinopathy / drug therapy*
Enzyme-Linked Immunosorbent Assay
Fluorescein Angiography
Fovea Centralis / pathology
Humans
Intraocular Pressure / physiology
Macular Edema / drug therapy*
Mecamylamine / administration & dosage*,  adverse effects
Nicotinic Antagonists / administration & dosage*,  adverse effects
Tomography, Optical Coherence
Treatment Outcome
Vascular Endothelial Growth Factor A / metabolism
Visual Acuity / physiology
Grant Support
ID/Acronym/Agency:
R01 CA098303/CA/NCI NIH HHS; R01 CA098303-04/CA/NCI NIH HHS; R01 EY012609/EY/NEI NIH HHS; R01 EY012609-10/EY/NEI NIH HHS
Chemical
Reg. No./Substance:
0/Nicotinic Antagonists; 0/VEGFA protein, human; 0/Vascular Endothelial Growth Factor A; 60-40-2/Mecamylamine
Comments/Corrections

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