Ocular Changes After Ivermectin - (DOLF IVM/Oncho)

The Washington University

Status

Completed

Conditions

Onchocerciasis

Treatments

Drug: Ivermectin 3Mg Tab

Study type

Interventional

Funder types

Other

Identifiers

NCT03517462

201804116

Details and patient eligibility

About

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).

Full 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.

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.

Enrollment

231 patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

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