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Ocular Changes After Ivermectin - (DOLF IVM/Oncho)

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ClinicalTrials.gov Identifier: NCT03517462
Recruitment Status : Not yet recruiting
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
Case Western Reserve University
University of Health and Allied Sciences
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Onchocerciasis Drug: Ivermectin 3Mg Tab Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microfilarial Clearance From the Eye and Ocular Changes Associated With Ivermectin Treatment in Individuals With Onchocerciasis
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Ivermectin
Single dose directly observed treatment with Ivermectin 3Mg Tab (150 ug/kg) delivered orally.
Drug: Ivermectin 3Mg Tab
ivermectin tablet




Primary Outcome Measures :
  1. Number of participants with complete microfilaria clearance from the eye at 3 months [ Time Frame: 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.

  2. Number of participants with complete microfilaria clearance from the eye at 6 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. The change from baseline in the number of microfilaria detected in the skin at 3 months [ Time Frame: 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.

  2. The change from baseline in the number of microfilaria detected in the skin at 6 months [ Time Frame: 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.

  3. The change from baseline in the number of microfilaria detected in the eye at 3 months [ Time Frame: baseline, 3 months following treatment ]
    Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment.

  4. The change from baseline in the number of microfilaria detected in the eye at 6 months [ Time Frame: baseline, 6 months following treatment ]
    Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment.

  5. Number of participants with complete microfilaria clearance from the skin at 3 months [ Time Frame: 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.

  6. Number of participants with complete microfilaria clearance from the skin at 6 months [ Time Frame: 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.


Other Outcome Measures:
  1. Assess the utility of optical coherence tomography for evaluating the presence and clearance of Mf in the anterior and posterior segments of the eye. [ Time Frame: baseline, 3 and 6 months following treatment ]
    Results from the optical coherence tomography (OCT) will be compared with slit lamp and other ocular examinations

  2. Evaluate ocular changes between baseline and 3 months following ivermectin treatment using OCT [ Time Frame: baseline, and 3 months following treatment ]
    Results from the optical coherence tomography (OCT) will be compared in participants pre and post treatment

  3. Evaluate ocular changes between baseline and 6 months following ivermectin treatment using OCT [ Time Frame: baseline, and 6 months following treatment ]
    Results from the optical coherence tomography (OCT) will be compared in participants pre and post treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517462


Contacts
Contact: Joshua Bogus, MPH 314-747-5758 jbogus@wustl.edu

Locations
Ghana
University of Health and Allied Sciences Not yet recruiting
Hohoe, Ghana
Contact: Nicholas Opoku, MB CHB MSC    +233 244776668    noopoku@uhas.edu.gh   
Sponsors and Collaborators
Washington University School of Medicine
Case Western Reserve University
University of Health and Allied Sciences
Investigators
Principal Investigator: Gary Weil, MD Washington University School of Medicine
Principal Investigator: Christopher King, MD PhD Case Western Reserve University

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03517462     History of Changes
Other Study ID Numbers: 201804116
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Datasets used for published results will be shared publically through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
mass drug administration
ophthalmology

Additional relevant MeSH terms:
Onchocerciasis
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents