CompletedNot Applicable

Ocular Changes After Ivermectin - (DOLF IVM/Oncho)

Ghana231 participantsStarted 2018-08-06

Plain-language 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).

Who can participate

Age range16 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants with complete microfilaria clearance from the eye at 3 months

Timeframe: 3 months following treatment

Number of participants with complete microfilaria clearance from the eye at 6 months

Timeframe: 6 months following treatment

Trial details

NCT IDNCT03517462

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-23

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