Safety and Efficacy of IDA for Onchocerciasis

• Status: Enrolling by invitation
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Case Western Reserve University; University of Health and Allied Sciences

Criteria

Inclusion Criteria:

• Men and women who were previously enrolled in the preceding Part I study (Protocol ID#201804116) and residing in the study area

• Must have at least palpable subcutaneous nodule (onchocercoma)

• Participants with baseline skin Mf counts less than or equal to 3 Mf/mg at the time of enrollment into the Part I study (Protocol ID#201804116)

Exclusion Criteria:

• Pregnant and breastfeeding mothers within 1 month of giving birth

• Severe eye disease at baseline including uveitis, severe glaucoma, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye as well as the list of ocular diseases as outlined below. All ocular disease exclusion criteria apply to either eye. Bilateral disease is not necessary to exclude a participant. A participant will be excluded if any of the criteria are met for one eye.

1. Any cataract of any type preventing clear visualization of fundus or imaging on Optical Coherence Tomography (OCT).

2. Severe retinal nerve fiber layer thinning in the superior and inferior quadrant analysis on Ocular Coherence Tomography of the optic nerve with a corresponding visual field defect of grade 2 or worse on the same eye.If Ocular Coherence Tomography is not available, the following exclusion criteria will apply: vertical Cup/disc ratio on fundoscopy (not by OCT reading) greater than or equal to 0.80.

3. Intraocular pressure (IOP) greater than or equal to 25 by Goldmann tonometry .12

4. Retinal Detachment or Retinal Break

5. Acute ocular infection (i.e., Viral conjunctivitis, corneal ulcer, endophthalmitis)

6. Optic Atrophy with visual field defect reproducible on confrontation visual field testing..

7. Exam consistent with Herpes Simplex Virus eye infection

8. Homonymous hemianopsia, quadrantanopsia, bitemporal hemianopsia, or central scotoma related to cerebral vascular disease by Automated Visual Field testing and confrontation visual field testing.

9. Acute Angle Closure Glaucoma

10. Gonioscopy grade 0 (slit) limiting ability to safely dilate patient

11. Severe Tremor, blepharospasm, or other voluntary or involuntary motor condition that prevents ability to examine patient with slit lamp, OCT, gonioscopy, IOP measurement, fundus photography, and Frequency doubling technology perimetry.

12. Cognitive impairment sufficient to prevent ability to understand and perform Visual Acuity Test with Tumbling E chart, confrontation visual field, slit lamp exam, or any other ocular exam component.

13. Optic nerve edema

14. Active retinopathy or retinitis not attributable to onchocercal disease

15. History of uveitis not associated with onchocercal disease

16. Any pre-existing chorioretinal scar or retinal degeneration and other significant retinal pathologies (foveomacular schisis, dystrophies, arterial macroaneurysms etc) involving the macula.

17. Severe ocular pain, that patient rates as 9 or 10 out of 10 pain.

18. Best corrected or pinhole visual acuity worse than 6/60 (20/200)

19. Age related macular degeneration (AMD)

• Significant comorbidities such as renal insufficiency, liver failure, or any other acute or chronic illness identified by study clinicians and investigators that interferes with the participant's ability to go to school or work or perform routine household chores.

• Prior allergic / hypersensitivity reactions or intolerance to IVM, ALB, or DEC.

• Treatment with IVM outside of the study after the pre-treatment clearing dose provided in the Part I study.

• >5 motile Mf in the anterior chamber in either eye at the time of enrollment (after pre-treatment with IVM).

• Any Mf identified in the posterior segment of the eye at the time of enrollment (six months after pre-treatment with IVM).

• Any other condition identified by study clinicians or investigators that may preclude participation in the study.