Ocular Changes After Ivermectin - (DOLF IVM/Oncho)

NCT03517462 | Completed

• 1 other identifier: 201804116
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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).

Conditions

Onchocerciasis

Keywords

mass drug administration; ophthalmology

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• The change from baseline in the number of microfilaria detected in the skin at 3 months

  baseline, and 3 months following treatment

• The change from baseline in the number of microfilaria detected in the skin at 6 months

  baseline, and 6 months following treatment

• The change from baseline in the number of microfilaria detected in the eye at 3 months

  baseline, 3 months following treatment

• The change from baseline in the number of microfilaria detected in the eye at 6 months

  baseline, 6 months following treatment

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

  3 months following treatment

Other Outcomes (3)

• Assess the utility of optical coherence tomography for evaluating the presence and clearance of Mf in the anterior and posterior segments of the eye.

  baseline, 3 and 6 months following treatment

• Evaluate ocular changes between baseline and 3 months following ivermectin treatment using OCT

  baseline, and 3 months following treatment

• Evaluate ocular changes between baseline and 6 months following ivermectin treatment using OCT

  baseline, and 6 months following treatment

Study Arms (1)

Ivermectin

EXPERIMENTAL

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

Drug: Ivermectin 3Mg Tab

Interventions

Ivermectin 3Mg Tab DRUG

ivermectin tablet

Ivermectin

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Case Western Reserve University: collaborator
• University of Health and Allied Sciences: collaborator

Study Sites (1)

University of Health and Allied Sciences

Hohoe, Ghana

Location

Related Publications (42)

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MeSH Terms

Conditions

Onchocerciasis

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Gary Weil, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Christopher King, MD PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are all given a standard treatment (ivermectin) for onchocerciasis.

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 7, 2018
• Study Start: August 6, 2018
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

GH (1)