HCV InfectionNCT04159246

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

An observational study of HCV Infection, run by Mohamed Saad at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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 Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: HCV Infection
What is being tested?: Optical coherence tomography angiography and Sofosbuvir (Sovaldi)
Type of treatment: Medical device
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 10 Feb 2019to 30 Nov 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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 )

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Cairo University - Kasr Alainy
Cairo

Other trials in Egypt

About this study

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

Read the 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 .

Conditions: HCV Infection
Being tested: Optical coherence tomography angiography, Sofosbuvir (Sovaldi)
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Optical coherence tomography angiographyDevice
Also called OCTA
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
Sofosbuvir (Sovaldi)Drug
Also called 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

Study groups in NCT04159246
Study group	Role	What they receive
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) Receives: Device: Optical coherence tomography angiography; Drug: Sofosbuvir (Sovaldi)

What is being measured

The primary outcome is the main question the study is designed to answer.

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..
Measured: 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 .
Measured: 3 months

Secondary outcomes (3)

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 .
Measured: 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)
Measured: 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 .
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 201930 Nov 2019

First posted12 Nov 2019
Study start10 Feb 2019
Primary completion30 Nov 2019 (estimated)
Study completion30 Nov 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HCV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04159246
Sponsor's protocol ID: s-5-2019
Status last verified: Nov 2019
First submitted: 1 Nov 2019
Last updated: 12 Nov 2019
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: All required non private data

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.
PubMed 27162457
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.
PubMed 26764884
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.
PubMed 29260058
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.
PubMed 27610281
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.
PubMed 23607594

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HCV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection
ClinicalTrials.gov ID: NCT04159246
Acronym / sponsor ID: s-5-2019
Conditions: HCV Infection
Study type: Observational
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Mohamed SaadUniversity, hospital or other
Study start: 10 Feb 2019 (actual)
Primary completion: 30 Nov 2019 (estimated)
Study completion: 30 Nov 2019 (estimated)
First posted: 12 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Sovaldi group	–	Device: Optical coherence tomography angiography, Drug: Sofosbuvir (Sovaldi)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)

Who may qualify

Ages: 20 to 80 years
Sex: All
Age groups: Adult, Older adult
Study population: Convenience sample 30 eyes of 30 patients with a documented diagnosis of chronic hepatitis C

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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 )

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Optical coherence tomography angiographyAlso: OCTARecent 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	Device	Sovaldi group
Sofosbuvir (Sovaldi)Also: SovaldiSofosbuvir (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	Drug	Sovaldi group

Primary outcome

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..
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 .

3 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
Background: PubMed 27162457Chebil 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.
Background: PubMed 26764884Salman 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.
Background: PubMed 29260058Manoharan 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.
Background: PubMed 27610281Chin 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.
Background: PubMed 23607594Lawitz 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.
Individual participant dataSharing planned: Yes. All required non private data

Related trials for HCV Infection

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hany E Elmekewy, MD principal investigator

Cairo University

Magada S Abdelaziz, MD principal investigator

Cairo University

Yomna A Abdelwahab, MD principal investigator

Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HCV Infection, run by Mohamed Saad at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment percentage of change in macular vessels density using OCTA (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04159246, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.