Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
231 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-06
Study Completion Date
2019-08-23
Brief Summary
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The DOLF Ocular Changes after Ivermectin study will investigate the kinetics of O. volvulus microfilaria (Mf) in the eye following treatment with ivermectin. The primary objective is to determine the proportion of participants with complete Mf clearance from the eye at 3 and 6 months following treatment with ivermectin (IVM).
Detailed Description
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This study will examine the kinetics of Mf clearance in the eye following ivermectin treatment. Previous studies have been unable to fully assess clearance Mf from the posterior chamber of the eye. This study will be the first to use optical coherence tomography (OCT) in patients with onchocerciasis to document parasites and pathology in the anterior and posterior chambers of the eye, and assess ocular changes following standard ivermectin treatment.
This will be a biomedical prospective cohort study.
The cohort will be stratified based on Mf levels to achieve approximately the following distribution of individuals with roughly one-third of participants in each group.
1. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg), but no observable Mf in eyes using slit lamp and indirect ophthalmoscopy
2. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and 1-10 Mf in either eye at baseline (based on the highest number counted in either eye)
3. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and \>10 Mf in either eye at baseline.
All participants recruited into the study will be treated with a single dose of ivermectin (150 ug/kg) by mouth under direct observation. This is the standard of care for treatment with onchocerciasis.
Participants will be evaluated following treatment with detailed parasitological and ocular examinations 7 days, 3 months and 6 months after treatment.
This will be a biomedical prospective cohort study.
The cohort will be stratified based on Mf levels to achieve approximately the following distribution of individuals with roughly one-third of participants in each group.
1. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg), but no observable Mf in eyes using slit lamp and indirect ophthalmoscopy
2. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and 1-10 Mf in either eye at baseline (based on the highest number counted in either eye)
3. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and \>10 Mf in either eye at baseline.
All participants recruited into the study will be treated with a single dose of ivermectin (150 ug/kg) by mouth under direct observation. This is the standard of care for treatment with onchocerciasis.
Participants will be evaluated following treatment with detailed parasitological and ocular examinations 7 days, 3 months and 6 months after treatment.
Conditions
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Onchocerciasis
Keywords
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mass drug administration
ophthalmology
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Participants are all given a standard treatment (ivermectin) for onchocerciasis.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Ivermectin
Single dose directly observed treatment with Ivermectin 3Mg Tab (150 ug/kg) delivered orally.
Group Type
EXPERIMENTAL
Ivermectin 3Mg Tab
Intervention Type
DRUG
ivermectin tablet
Interventions
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Ivermectin 3Mg Tab
ivermectin tablet
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Have at least 1 palpable subcutaneous nodule (onchocercoma) and ≥ 1 Mf/mg of skin (by skin snip)
Exclusion Criteria
* Pregnancy and breastfeeding mothers within 1 month of giving birth
* Have base line eye diseases including glaucoma, uveitis, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye.
* Prior allergic / hypersensitivity reactions or intolerance to ivermectin
* Treatment with ivermectin in the past 6 (six) months
* Have base line eye diseases including glaucoma, uveitis, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye.
* Prior allergic / hypersensitivity reactions or intolerance to ivermectin
* Treatment with ivermectin in the past 6 (six) months
Minimum Eligible Age
16 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Case Western Reserve University
OTHER
Sponsor Role
collaborator
University of Health and Allied Sciences
OTHER
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Gary Weil, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Christopher King, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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University of Health and Allied Sciences
Hohoe, , Ghana
Site Status
Countries
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Ghana
References
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Other Identifiers
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201804116
Identifier Type: -
Identifier Source: org_study_id