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

NCT04159246 | Unknown FDA Drug FDA Device

• 1 other identifier: s-5-2019
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• amount of ocular dryness with Sofosbuvir using tear up breaking test

  3 months

• Role of Optical coherence tomography angiography (OCTA) in detection early signs retinopathy depending on changes in vascular density

  3 months

• amount of ocular dryness with Sofosbuvir using Schirmer's

  3 months

Study Arms (1)

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; Drug: Sofosbuvir (Sovaldi)

Interventions

Optical coherence tomography angiography DEVICE

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

Also known as: OCTA

Sovaldi group

Sofosbuvir (Sovaldi) DRUG

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

Also known as: Sovaldi

Sovaldi group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Convenience sample 30 eyes of 30 patients with a documented diagnosis of chronic hepatitis C

You may qualify if:

• 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Mohamed Saad: lead

Study Sites (1)

Cairo University - Kasr Alainy

Cairo, Egypt

Location

Related Publications (5)

• 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.

  PMID: 27162457 BACKGROUND

• 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.

  PMID: 26764884 BACKGROUND

• 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.

  PMID: 29260058 BACKGROUND

• 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.

  PMID: 27610281 BACKGROUND

• 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.

  PMID: 23607594 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Hany E Elmekewy, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Magada S Abdelaziz, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Yomna A Abdelwahab, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Mai I Mehrez, MD

  National Hepatology & Tropical Medicine Research Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident of Ophthalmology , Cairo University - researcher

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 12, 2019
• Study Start: February 10, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 30 November 2019
• Access Criteria: upon request of Any qualified and specialized Doctor or medical journal

Locations

EG (1)