Ocular Changes After Ivermectin - (DOLF IVM/Oncho)

Not Applicable

Completed

• Conditions: Onchocerciasis
• Interventions: Drug: Ivermectin 3Mg Tab

• Registration Number: NCT03517462
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-07
• Study Start: 2018-08-06
• Primary Completion: 2019-08-23
• Study Completion: 2019-08-23
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

• Have at least 1 palpable subcutaneous nodule (onchocercoma) and ≥ 1 Mf/mg of skin (by skin snip)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ivermectin	Ivermectin 3Mg Tab	Single dose directly observed treatment with Ivermectin 3Mg Tab (150 ug/kg) delivered orally.

Primary Outcome Measures

Name	Time	Method
Number of participants with complete microfilaria clearance from the eye at 6 months	6 months following treatment	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.
Number of participants with complete microfilaria clearance from the eye at 3 months	3 months following treatment	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.

Secondary Outcome Measures

Name	Time	Method
The change from baseline in the number of microfilaria detected in the skin at 3 months	baseline, and 3 months following treatment	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.
The change from baseline in the number of microfilaria detected in the skin at 6 months	baseline, and 6 months following treatment	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.
The change from baseline in the number of microfilaria detected in the eye at 3 months	baseline, 3 months following treatment	Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment.
The change from baseline in the number of microfilaria detected in the eye at 6 months	baseline, 6 months following treatment	Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment.
Number of participants with complete microfilaria clearance from the skin at 3 months	3 months following treatment	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.
Number of participants with complete microfilaria clearance from the skin at 6 months	6 months following treatment	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.

Trial Locations

Locations (1)

University of Health and Allied Sciences; 🇬🇭 Hohoe, Ghana