Active — Not RecruitingPhase 2

Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis

Liberia300 participantsStarted 2024-04-05

Plain-language summary

This study will investigate the safety and effectiveness of combination regimens in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

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

Exclusion criteria

✕. Any cataract that prevents clear visualization of fundus or imaging by OCT.
✕. Severe retinal nerve fiber layer thinning of the optic nerve in the superior and inferior quadrant analysis by OCT with a corresponding visual field defect in the superior and inferior hemifield, and/or visual field loss within 5 degrees of fixation in at least one hemifield. Note: If OCT is not available, the following exclusion criteria will apply: vertical cup/disc ratio by fundoscopy greater than or equal to 0.80 with a corresponding visual field defect in the superior and inferior hemifield, and/or visual field loss within 5 degrees of fixation in at least one hemifield.
✕. Intraocular pressure (IOP) greater than or equal to 25 by Goldmann tonometry.
✕. Retinal detachment or retinal break.
✕. Acute ocular infection (i.e., viral conjunctivitis, corneal ulcer, endophthalmitis).
✕. Optic atrophy with a reproducible visual field defect detected by confrontation visual field testing.
✕. Exam consistent with Herpes simplex virus eye infection.
✕. Homonymous hemianopsia, quadrantopsia, bitemporal hemianopsia, or central scotoma related to cerebral vascular disease by Automated Visual field testing and confrontation visual field testing.

What they're measuring

Rates and types of severe or serious adverse events within 6 months following Ivermectin treatments

Timeframe: Baseline to 6 months

Rates and types of severe or serious adverse events within 6 months following Moxidectin treatments

Timeframe: Baseline to 6 months

Proportion of all adult female worms that are fertile 24 months after first treatment

Timeframe: 24 months

Trial details

NCT IDNCT06070116

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More Onchocercal Subcutaneous Nodule trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

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

Exclusion criteria

✕. Any cataract that prevents clear visualization of fundus or imaging by OCT.
✕. Severe retinal nerve fiber layer thinning of the optic nerve in the superior and inferior quadrant analysis by OCT with a corresponding visual field defect in the superior and inferior hemifield, and/or visual field loss within 5 degrees of fixation in at least one hemifield. Note: If OCT is not available, the following exclusion criteria will apply: vertical cup/disc ratio by fundoscopy greater than or equal to 0.80 with a corresponding visual field defect in the superior and inferior hemifield, and/or visual field loss within 5 degrees of fixation in at least one hemifield.
✕. Intraocular pressure (IOP) greater than or equal to 25 by Goldmann tonometry.
✕. Retinal detachment or retinal break.
✕. Acute ocular infection (i.e., viral conjunctivitis, corneal ulcer, endophthalmitis).
✕. Optic atrophy with a reproducible visual field defect detected by confrontation visual field testing.
✕. Exam consistent with Herpes simplex virus eye infection.
✕. Homonymous hemianopsia, quadrantopsia, bitemporal hemianopsia, or central scotoma related to cerebral vascular disease by Automated Visual field testing and confrontation visual field testing.

What they're measuring

Rates and types of severe or serious adverse events within 6 months following Ivermectin treatments

Timeframe: Baseline to 6 months

Rates and types of severe or serious adverse events within 6 months following Moxidectin treatments

Timeframe: Baseline to 6 months

Proportion of all adult female worms that are fertile 24 months after first treatment

Timeframe: 24 months