Ocular Changes After Ivermectin - (DOLF IVM/Oncho)

Study Overview
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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. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg), but no observable Mf in eyes using slit lamp and indirect ophthalmoscopy 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) 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.

Official Title
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Microfilarial Clearance From the Eye and Ocular Changes Associated With Ivermectin Treatment in Individuals With Onchocerciasis

Conditions
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Onchocerciasis

Intervention / Treatment
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* Drug: Ivermectin 3Mg Tab


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Participants are all given a standard treatment (ivermectin) for onchocerciasis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin<br>Single dose directly observed treatment with Ivermectin 3Mg Tab (150 ug/kg) delivered orally. | Drug: Ivermectin 3Mg Tab<br>* ivermectin tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complete microfilaria clearance from the eye at 3 months | Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. Participants without Mf in the eye will be considered clear of infection in the eye. | 3 months following treatment | 
| Number of participants with complete microfilaria clearance from the eye at 6 months | Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. Participants without Mf in the eye will be considered clear of infection in the eye. | 6 months following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in the number of microfilaria detected in the skin at 3 months | Microfilaria (Mf) in the skin will be detected by skin snip microscopy. Up to four (4) skin snips using a corneoscleral punch will be weighed on an analytical balance and incubated for at least 8 hours in isotonic saline in a well of a flat-bottomed microtitre plate at ambient temperature. The Mf that have emerged will be counted using a microscope. Mf number and skin snip weight will be recorded. The mean skin microfilarial density will be calculated and recorded as mf/mg. | baseline, and 3 months following treatment | 
| The change from baseline in the number of microfilaria detected in the skin at 6 months | Microfilaria (Mf) in the skin will be detected by skin snip microscopy. Up to four (4) skin snips using a corneoscleral punch will be weighed on an analytical balance and incubated for at least 8 hours in isotonic saline in a well of a flat-bottomed microtitre plate at ambient temperature. The Mf that have emerged will be counted using a microscope. Mf number and skin snip weight will be recorded. The mean skin microfilarial density will be calculated and recorded as mf/mg. | baseline, and 6 months following treatment | 
| The change from baseline in the number of microfilaria detected in the eye at 3 months | Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. | baseline, 3 months following treatment | 
| The change from baseline in the number of microfilaria detected in the eye at 6 months | Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. | baseline, 6 months following treatment | 
| Number of participants with complete microfilaria clearance from the skin at 3 months | Microfilaria (Mf) in the skin will be detected by skin snip microscopy. Up to four (4) skin snips using a corneoscleral punch will be weighed on an analytical balance and incubated for at least 8 hours in isotonic saline in a well of a flat-bottomed microtitre plate at ambient temperature. The Mf that have emerged will be counted using a microscope. Mf number and skin snip weight will be recorded. Participants without Mf in the skin will be considered clear of infection in the skin. | 3 months following treatment | 
| Number of participants with complete microfilaria clearance from the skin at 6 months | Microfilaria (Mf) in the skin will be detected by skin snip microscopy. Up to four (4) skin snips using a corneoscleral punch will be weighed on an analytical balance and incubated for at least 8 hours in isotonic saline in a well of a flat-bottomed microtitre plate at ambient temperature. The Mf that have emerged will be counted using a microscope. Mf number and skin snip weight will be recorded. Participants without Mf in the skin will be considered clear of infection in the skin. | 6 months following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mass drug administration, ophthalmology