Ocular Changes After Ivermectin - (DOLF IVM/Oncho)

Onchocerciasis Clinical Trial

Official title:

Microfilarial Clearance From the Eye and Ocular Changes Associated With Ivermectin Treatment in Individuals With Onchocerciasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517462
• Other study ID #: 201804116
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: August 23, 2019

Study information

• Verified date: December 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: August 23, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Onchocerciasis

Intervention

Drug:
• Ivermectin 3Mg Tab
ivermectin tablet

Locations

Country	Name	City	State
Ghana	University of Health and Allied Sciences	Hohoe

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Case Western Reserve University, University of Health and Allied Sciences

Country where clinical trial is conducted

Ghana, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess the utility of optical coherence tomography for evaluating the presence and clearance of Mf in the anterior and posterior segments of the eye.	Results from the optical coherence tomography (OCT) will be compared with slit lamp and other ocular examinations	baseline, 3 and 6 months following treatment
Other	Evaluate ocular changes between baseline and 3 months following ivermectin treatment using OCT	Results from the optical coherence tomography (OCT) will be compared in participants pre and post treatment	baseline, and 3 months following treatment
Other	Evaluate ocular changes between baseline and 6 months following ivermectin treatment using OCT	Results from the optical coherence tomography (OCT) will be compared in participants pre and post treatment	baseline, and 6 months following treatment
Primary	Number of participants with complete microfilaria clearance from the eye at 3 months	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.	3 months following treatment
Primary	Number of participants with complete microfilaria clearance from the eye at 6 months	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.	6 months following treatment
Secondary	The change from baseline in the number of microfilaria detected in the skin at 3 months	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.	baseline, and 3 months following treatment
Secondary	The change from baseline in the number of microfilaria detected in the skin at 6 months	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.	baseline, and 6 months following treatment
Secondary	The change from baseline in the number of microfilaria detected in the eye at 3 months	Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment.	baseline, 3 months following treatment
Secondary	The change from baseline in the number of microfilaria detected in the eye at 6 months	Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment.	baseline, 6 months following treatment
Secondary	Number of participants with complete microfilaria clearance from the skin at 3 months	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.	3 months following treatment
Secondary	Number of participants with complete microfilaria clearance from the skin at 6 months	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.	6 months following treatment