Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir in Patients With Hepatitis C

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: NCT04159246
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Saad, Cairo University

Brief Summary:
The purpose of this study is to prospectively evaluate the value of Optical coherence tomography angiography (OCT-A) for the of detection of suspected retinal complications With Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection

Condition or disease Intervention/treatment
HCV Infection Device: Optical coherence tomography angiography Drug: Sofosbuvir (Sovaldi)

Detailed Description:

During 3 months duration ( the treatment course duration) , Optical coherence tomography angiography (OCT-A) will be performed to 30 eyes of 30 patients with a documented diagnosis of chronic hepatitis C before and after receiving dual-therapy planning (Daclatasvir - Sofosbuvir (Sovaldi)) , normal renal functions And Rheumatoid factor tests , will undergo a comprehensive ophthalmic examination including:

  • Manifest refraction
  • Corrected distance visual acuity
  • Anterior segment examination using slit lamp and tear film breakup time test
  • Fundus examination

Recent Optical coherence tomography angiography (OCT-A) will be performed to all patients before Treatment Administration.

Examination will be performed using "Optovue AngioVue®" "Optovue, Inc., Fremont, CA", which uses split-spectrum amplitude-decorrelation angiography algorithm, which minimizes motion noise. This system also allows quantitative analysis, since it provides numerical data about flow area and flow density maps.

The patient will be examined before and after finishing the treatment course

* Optical coherence tomography angiography (OCT-A) image acquisition OCT-A will be done for all patients who are instructed to focus on a fixation target. OCTA images are obtained using the "RTVue XR Avanti (AngioVue; Optovue Inc, Fremont, California, USA)" machine and the incorporated "AngioVue OCT-A" system. Algorithm used is Split-Spectrum Amplitude Decorrelation Algorithm (SSADA). The scans which will be included in the study are of high signal strength more than 0.7 and they will be carefully inspected for motion artifacts. Automatic segmentation of intraretinal layers will be done using the automated software of the machine (version 2016.2.0; Optovue Inc). Angio-retina scan sizes in this study will be 6 X 6 mm for all eyes. Assessment of the macular vessel density will be done for superficial vascular layer, capillary plexus, deep capillary plexus and all retinal plexuses). Assessment of the foveal avascular zone on both superficial vascular layer (SVL) and deep capillary plexuses (DCP); including its size, perimeter and circularity (regularity) index. Circularity index is a measure of compactness of a shape relative to a circle. The circularity index of a circle is 1.0. Thus, a ratio closer to 0 indicates an irregular shape, and that closer to 1.0 indicates a circular shape.

All results will be in numerical values (percentage) to compare retinal vascularity before and after using the drug. Best corrected visual acuity (in values from o.o5 to 1.0) , dryness (in seconds) will be also measured before and after drug administration and it will be compared .

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection
Actual Study Start Date : February 10, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Group/Cohort Intervention/treatment
Sovaldi group
patients with a documented diagnosis of chronic hepatitis C , normal renal functions And Rheumatoid factor tests (to exclude Purtscher like retinopathy as a rare presentation of cryoglobuinemia which considered one of extra hepatic manifestations of HCV)
Device: Optical coherence tomography angiography

Recent Optical coherence tomography angiography "OCT-A" will be performed to all patients before Treatment Administration.

  • Examination will be performed using Optovue AngioVue® "Optovue, Inc., Fremont, CA", which uses split-spectrum amplitude-decorrelation angiography algorithm, which minimizes motion noise. This system also allows quantitative analysis, since it provides numerical data about flow area and flow density maps.
  • The patient will be examined before and after finishing the treatment course
Other Name: OCTA

Drug: Sofosbuvir (Sovaldi)
Sofosbuvir (tradename Sovaldi) is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C , here it's used with Daclatasvir for 3 months
Other Name: Sovaldi




Primary Outcome Measures :
  1. Assessment percentage of change in macular vessels density using OCTA [ Time Frame: 3 months ]
    Evaluate the suspected retinal vascular complications With Sofosbuvir (Sovaldi) ) in Patients With Hepatitis C Virus Infection, All results will be in numerical values (percentage) to compare retinal vascularity before and after using the drug..

  2. visual acuity changes with Sofosbuvir [ Time Frame: 3 months ]
    Comparing best corrected visual acuity (in values from o.o5 to 1.0) before and after drug administration .


Secondary Outcome Measures :
  1. amount of ocular dryness with Sofosbuvir using tear up breaking test [ Time Frame: 3 months ]
    Measuring amount of ocular dryness using Tear-up breaking test, dryness will be evaluated in seconds before and after drug administration and it will be compared .

  2. Role of Optical coherence tomography angiography (OCTA) in detection early signs retinopathy depending on changes in vascular density [ Time Frame: 3 months ]
    Confirm the advantages of Optical coherence tomography angiography (OCT - A) in detection early signs retinopathy depending on changes in vascular density (evaluated as a percentage)

  3. amount of ocular dryness with Sofosbuvir using Schirmer's [ Time Frame: 3 months ]
    Measuring amount of ocular dryness using Tear-up breaking test, dryness will be evaluated in millimeters of wetness of schirmer's strips before and after drug administration and it will be compared .



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.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample 30 eyes of 30 patients with a documented diagnosis of chronic hepatitis C
Criteria

Inclusion Criteria:

  • Age between 20 and 80 years.
  • Patients with chronic hepatitis C enrolled for (Daclatasvir - Sofosbuvir (Sovaldi)) .
  • Patients who have normal ocular and fundoscopic examination before the onset of treatment.

Exclusion Criteria:

  • Relapsed cases who have formerly taken the antiviral therapy (depending on the basis of medical record and filing system), or treated with interferon for any other cause .
  • Patients with elevated renal functions or positive Rheumatoid factor (as a clue to diagnose Purtscher like retinopathy which is a rare presentation of cryoglobulinemia ,considered one of extra hepatic manifestations of HCV )

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): NCT04159246


Locations
Layout table for location information
Egypt
Cairo University - Kasr Alainy
Cairo, Egypt
Sponsors and Collaborators
Mohamed Saad
Investigators
Layout table for investigator information
Principal Investigator: Hany E Elmekewy, MD Cairo University
Principal Investigator: Magada S Abdelaziz, MD Cairo University
Principal Investigator: Yomna A Abdelwahab, MD Cairo University
Study Chair: Mai I Mehrez, MD National Hepatology & Tropical Medicine Research Institute
  Study Documents (Full-Text)

Documents provided by Mohamed Saad, Cairo University:
Informed Consent Form  [PDF] August 15, 2019
Study Protocol  [PDF] August 15, 2019

Publications:
Layout table for additonal information
Responsible Party: Mohamed Saad, Resident of Ophthalmology , Cairo University - researcher, Cairo University
ClinicalTrials.gov Identifier: NCT04159246    
Other Study ID Numbers: s-5-2019
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All required non private data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 30 November 2019
Access Criteria: upon request of Any qualified and specialized Doctor or medical journal

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents