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PREVAIL VII: Persistence of Ebola Virus in Aqueous Humor and Outcomes of Cataract Surgery in Survivors of Ebola Virus Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309020
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Brief Summary:

Objective: Zaire ebolavirus is a single-stranded RNA virus associated with high morbidity and mortality. The most recent epidemic of Ebola virus disease (EVD) in West Africa resulted in over 11,000 deaths and disabling sequelae among survivors, among which eye complications are highly represented. Chronic intraocular inflammation and viral persistence may result in posterior synechiae and cataract formation, resulting in loss of visual acuity and requiring surgical intervention to resolve. Approximately one out of ten Ebola survivors present with cataract, most of whom will require intraocular surgery during their lifetime, and many of whom require intervention in the near future to regain quality of life. For survivors who are blind from cataract, cataract extraction is necessary to restore visual function, allow reintegration into society and facilitate performance of activities of daily living.

However, surgical parameters among Ebola survivors are unknown, including whether Ebola viral RNA persists in aqueous humor, whether additional anti-inflammatory medication is needed, and the expected degree of improvement in visual function. Moreover, sites of viral persistence are unknown, and it is unclear if lens tissues removed during cataract surgery may harbor virus in Ebola-affected eyes. We propose following EVD survivors and control subjects undergoing cataract surgery to determine visual outcomes among Ebola survivors and explore detection of the presence of virus in lens tissues. The data will inform both future surgical intervention and aid in the understanding of the pathophysiology of Ebola-associated eye disease.

Study Population: Up to 60 Ebola survivors and up to 60 controls will be enrolled. The accrual ceiling is 120 participants.

Design: This is a prospective, natural history study to evaluate the persistence of Ebola viral RNA in the eyes of Ebola survivors and assess the response to cataract surgery in survivors as compared to controls. EVD survivors will first undergo assessment of aqueous humor for the presence of viral RNA. Survivors testing negative for viral RNA and control subjects will undergo clinically indicated cataract surgery. Subjects will be evaluated 1 day, 1 week, 1 month, 3 months, and 6 months after surgery for safety and visual outcome assessments, and more often as clinically indicated.

Outcome Measures: The primary outcomes are: 1) the proportion of EVD survivors with evidence of persistence of Ebola viral RNA in ocular tissue and 2) the comparison of amount of intraocular inflammation, as measured by average grade of anterior chamber cell by SUN criteria, between EVD survivors and controls at 1 month and 3 months following cataract surgery. Secondary outcomes include: 1) the proportion of survivors with at least 20/40 best corrected visual acuity (BCVA) after cataract surgery, relative to controls; 2) significance of covariates, age and gender, in logistic regression assessment of viral persistence and cataract outcomes; 3) post-operative optical coherence tomography results in EVD survivors.


Condition or disease Intervention/treatment Phase
Cataract Procedure: Cataract Phase 1 Phase 2

Detailed Description:

Objective: Zaire ebolavirus is a single-stranded RNA virus associated with high morbidity and mortality. The most recent epidemic of Ebola virus disease (EVD) in West Africa resulted in over 11,000 deaths and disabling sequelae among survivors, among which eye complications are highly represented. Chronic intraocular inflammation and viral persistence may result in posterior synechiae and cataract formation, resulting in loss of visual acuity and requiring surgical intervention to resolve. Approximately one out of ten Ebola survivors present with cataract, most of whom will require intraocular surgery during their lifetime, and many of whom require intervention in the near future to regain quality of life. For survivors who are blind from cataract, cataract extraction is necessary to restore visual function, allow reintegration into society and facilitate performance of activities of daily living.

However, surgical parameters among Ebola survivors are unknown, including whether Ebola viral RNA persists in aqueous humor, whether additional anti-inflammatory medication is needed, and the expected degree of improvement in visual function. Moreover, sites of viral persistence are unknown, and it is unclear if lens tissues removed during cataract surgery may harbor virus in Ebola-affected eyes. We propose following EVD survivors and control subjects undergoing cataract surgery to determine visual outcomes among Ebola survivors and explore detection of the presence of virus in lens tissues. The data will inform both future surgical intervention and aid in the understanding of the pathophysiology of Ebola-associated eye disease.

Study Population: Up to 60 Ebola survivors and up to 60 controls will be enrolled. The accrual ceiling is 120 participants.

Design: This is a prospective, natural history study to evaluate the persistence of Ebola viral RNA in the eyes of Ebola survivors and assess the response to cataract surgery in survivors as compared to controls. EVD survivors will first undergo assessment of aqueous humor for the presence of viral RNA. Survivors testing negative for viral RNA and control subjects will undergo clinically indicated cataract surgery. Subjects will be evaluated 1 day, 1 week, 1 month, and 3, 6, 9 and 12 months after surgery for safety and visual outcome assessments, and more often as clinically indicated.

Outcome Measures: The primary outcomes are: 1) the proportion of EVD survivors with evidence of persistence of Ebola viral RNA in ocular tissue and 2) the comparison of amount of intraocular inflammation, as measured by average grade of anterior chamber cell by SUN criteria, between EVD survivors and controls at 1 month and 3 months following cataract surgery. Secondary outcomes include: 1) the proportion of survivors with at least 20/40 best corrected visual acuity (BCVA) after cataract surgery, relative to controls; 2) impact the of covariates, age and gender on viral persistence and cataract outcomes; 3) post-operative optical coherence tomography results in EVD survivors.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PREVAIL VII: Persistence of Ebola Virus in Aqueous Humor and Outcomes of Cataract Surgery in Survivors of Ebola Virus Disease
Actual Study Start Date : September 5, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Ebola

Arm Intervention/treatment
Active Comparator: Control
Control with clinical need for cataract surgery
Procedure: Cataract
Cataract surgery and aqueous humor sampling.

Experimental: EVD Survivors
EVD survivors with need for cataract surgery
Procedure: Cataract
Cataract surgery and aqueous humor sampling.




Primary Outcome Measures :
  1. Determine the proportion of EVD survivors with evidence of persistence of Ebola viral RNA in ocular tissue [ Time Frame: One year ]
    Level of Ebola virus in ocular tissue.

  2. Compare the amount of intraocular inflammation [ Time Frame: One year ]
    Average grade of anterior chamber cell by SUN criteria.


Secondary Outcome Measures :
  1. Assess visual outcomes of cataract surgery in EVD survivors [ Time Frame: 1 year ]
    Assess visual outcomes of cataract surgery in EVD survivors

  2. Assess the effect of age and gender on Ebola virus persistence and cataract outcomes in EVD survivors [ Time Frame: 1 year ]
    Assess the effect of age and gender on Ebola virus persistence and cataract outcomes in EVD survivors

  3. Assess postoperative structural changes after intraocular surgery in EVD survivors. [ Time Frame: 1 year ]
    Assess postoperative structural changes after intraocular surgery in EVD survivors.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

To be eligible, the following inclusion criteria must be met, where applicable.

  1. Participant must be 14 years of age or older.
  2. Participant must be able to understand and sign an informed consent or have a parent/legal guardian do so if they are minor children or a legally authorized representative to provide consent for adults without consent capacity.
  3. Participant must be either:

    • an Ebola virus disease (EVD) seropositive survivor or seropositive control OR
    • an EVD seronegative survivor or seronegative control (Serology confirmation is available for PREVAIL participants and will be conducted for non-PREVAIL participants.).
  4. Participant must have visually significant cataract(s) consistent with level of visual deficit.
  5. Participant must have corrected visual acuity worse than 20/40 in affected eye and vision loss believed to be primarily the result of the cataract.
  6. Any woman and persons of childbearing potential age have a negative pregnancy test at screening and must be willing to undergo pregnancy testing prior to the cataract surgery.

EXCLUSION CRITERIA:

A participant is not eligible if any of the following exclusion criteria are present.

  1. Concurrent life-threatening illness or other condition that compromises a participant s ability to safely undergo surgery, as determined by the surgical and medical team, including any condition that prevents the participant from lying down supine or remaining still, such as severe lung disease, or a known life-threatening, untreated or unstable cardiac or pulmonary condition.
  2. Active uveitis at time of surgery or within the past three months, if documented.
  3. Participant is pregnant, as surgery is elective and no adequate data regarding the use of postoperative topical antibiotic-steroid combination drops exists in pregnant women.
  4. Any condition that poses a risk to the participant having a safe surgical or post-operative experience, including known inability or unwillingness to follow up for the full duration of the protocol.

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): NCT03309020


Locations
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Liberia
JFK Hospital
Monrovia, Liberia
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
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Principal Investigator: Teresa M Magone de Quadros Costa, M.D. National Eye Institute (NEI)

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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT03309020    
Other Study ID Numbers: 999917167
17-EI-N167
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 15, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
OCT
Cataracts
Visual Acuity
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Cataract
Virus Diseases
Lens Diseases
Eye Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections