Clinical trial NCT03517462: Ocular Changes After Ivermectin - (DOLF IVM/Oncho)
Official title: Microfilarial Clearance From the Eye and Ocular Changes Associated With Ivermectin Treatment in Individuals With Onchocerciasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onchocerciasis
Keywords: mass drug administration
ophthalmology
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: University of Health and Allied Sciences
First posted: 2018-05-07
Enrollment: 231
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are all given a standard treatment (ivermectin) for onchocerciasis.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with complete microfilaria clearance from the eye at 3 months
timeFrame: 3 months following treatment
measure: Number of participants with complete microfilaria clearance from the eye at 6 months
timeFrame: 6 months following treatment
Secondary outcomes:
measure: The change from baseline in the number of microfilaria detected in the skin at 3 months
timeFrame: baseline, and 3 months following treatment
measure: The change from baseline in the number of microfilaria detected in the skin at 6 months
timeFrame: baseline, and 6 months following treatment
measure: The change from baseline in the number of microfilaria detected in the eye at 3 months
timeFrame: baseline, 3 months following treatment
measure: The change from baseline in the number of microfilaria detected in the eye at 6 months
timeFrame: baseline, 6 months following treatment
measure: Number of participants with complete microfilaria clearance from the skin at 3 months
timeFrame: 3 months following treatment
measure: Number of participants with complete microfilaria clearance from the skin at 6 months
timeFrame: 6 months following treatment
Other outcomes:
measure: Assess the utility of optical coherence tomography for evaluating the presence and clearance of Mf in the anterior and posterior segments of the eye.
timeFrame: baseline, 3 and 6 months following treatment
measure: Evaluate ocular changes between baseline and 3 months following ivermectin treatment using OCT
timeFrame: baseline, and 3 months following treatment
measure: Evaluate ocular changes between baseline and 6 months following ivermectin treatment using OCT
timeFrame: baseline, and 6 months following treatment
Locations:
city: Hohoe
country: Ghana
facility: University of Health and Allied Sciences
Study officials:
affiliation: Washington University School of Medicine
name: Gary Weil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Christopher King, MD PhD
role: PRINCIPAL_INVESTIGATOR
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