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

Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection

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

Study Overview

• Status: Unknown
• Conditions: HCV Infection
• Intervention / Treatment: 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 .

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University - Kasr Alainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

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 )

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: 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 Names: Sovaldi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment percentage of change in macular vessels density using OCTA	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..	3 months
visual acuity changes with Sofosbuvir	Comparing best corrected visual acuity (in values from o.o5 to 1.0) before and after drug administration .	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of ocular dryness with Sofosbuvir using tear up breaking test	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 .	3 months
Role of Optical coherence tomography angiography (OCTA) in detection early signs retinopathy depending on changes in vascular density	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 months
amount of ocular dryness with Sofosbuvir using Schirmer's	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 .	3 months

Collaborators and Investigators

• Sponsor: Mohamed Saad
• Investigators: 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

Publications and helpful links

General Publications

• Chebil A, Mammouri R, Abdallah MB, El Matri L. Purtscher-like Retinopathy as a Rare Presentation of Cryoglobulinemia. Middle East Afr J Ophthalmol. 2016 Apr-Jun;23(2):219-21. doi: 10.4103/0974-9233.177409.
• Salman AG. Ocular Surface Changes With Sofosbuvir in Egyptian Patients With Hepatitis C Virus Infection. Cornea. 2016 Mar;35(3):323-8. doi: 10.1097/ICO.0000000000000736.
• Manoharan N, Subramanian PS. A case of non-arteritic anterior ischemic optic neuropathy after completion of Harvoni therapy. Am J Ophthalmol Case Rep. 2017 Mar 8;6:55-57. doi: 10.1016/j.ajoc.2017.03.002. eCollection 2017 Jun.
• Chin Loy K, Galaydh F, Shaikh S. Correction: Retinopathy and Uveitis Associated with Sofosbuvir Therapy for Chronic Hepatitis C Infection. Cureus. 2016 Jul 14;8(7):c3. doi: 10.7759/cureus.c3.
• Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2019
• Primary Completion (ANTICIPATED): November 30, 2019
• Study Completion (ANTICIPATED): November 30, 2019

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (ACTUAL): November 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Infections; Hepatitis C; Anti-Infective Agents; Antiviral Agents; Sofosbuvir
• Other Study ID Numbers: s-5-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All required non private data
• IPD Sharing Time Frame: 30 November 2019
• IPD Sharing Access Criteria: upon request of Any qualified and specialized Doctor or medical journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• 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