Clinical trial NCT04159246: Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir in Patients With Hepatitis C
Official title: Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HCV Infection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sample 30 eyes of 30 patients with a documented diagnosis of chronic hepatitis C

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

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 .

Eligibility 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 )

Primary outcomes:
measure: Assessment percentage of change in macular vessels density using OCTA
timeFrame: 3 months
measure: visual acuity changes with Sofosbuvir
timeFrame: 3 months
Secondary outcomes:
measure: amount of ocular dryness with Sofosbuvir using tear up breaking test
timeFrame: 3 months
measure: Role of Optical coherence tomography angiography (OCTA) in detection early signs retinopathy depending on changes in vascular density
timeFrame: 3 months
measure: amount of ocular dryness with Sofosbuvir using Schirmer's
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University - Kasr Alainy
Study officials:
affiliation: Cairo University
name: Hany E Elmekewy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Magada S Abdelaziz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Yomna A Abdelwahab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Hepatology & Tropical Medicine Research Institute
name: Mai I Mehrez, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.