Infection ViralNCT03598452
High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative Patients
A study testing Ganciclovir in people with Infection Viral and Uveitis, Posterior, run by Aier School of Ophthalmology, Central South University.
Trial summary
This prospective, non-randomized, non-controlled clinical trial was conducted to examine the clinical outcomes achieved by using initial high-dose intravitreal ganciclovir injections of ganciclovir in treating cytomegalovirus (CMV) retinitis in patients without human immunodeficiency virus (HIV) infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection Viral, Uveitis, Posterior
- What is being tested?
- Ganciclovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with CMVR by ophthalmological examination
- Positive CMV-DNA in aqueous humor approved by real-time PCR.
- HIV-negative.
Who cannot join
- Diabetic retinopathy,
- Glaucoma.
- Optic neuritis.
About this study
Official title: A Prospective, Non-randomized, Non-controlled Trial: Initial Intravitreal Injection of High-dose Ganciclovir for Cytomegalovirus Retinitis in HIV-negative Patients
This prospective, non-randomized, non-controlled clinical trial was conducted to examine the clinical outcomes achieved by using initial high-dose intravitreal ganciclovir injections of ganciclovir in treating cytomegalovirus (CMV) retinitis in patients without human immunodeficiency virus (HIV) infection.
Read the detailed description
Cytomegalovirus retinitis (CMVR) is a serious vision-threatening disease. Intravitreal antiviral drug delivery was used as first-line treatment in several studies when systematic injection has been ruled out. The reported dose of intravitreal injections of ganciclovir (IVG) varied from 200 μg/0.1 ml to 5mg/0.1 ml in patients with AIDS. There was no consensus on the dose of ganciclovir in the treatment of CMVR in HIV-negative patients. Previous work showed the safety and the efficacy of 1mg IVG. The investigators proposed that a higher dose of ganciclovir (6mg/0.1ml) for the first injection followed by lower dose for maintenance may indicate a better result. Therefore, this study was performed to evaluate the therapeutic effect and safety of initial high-dose IVG for CMVR in HIV-negative patients.
- Conditions
- Infection Viral, Uveitis, Posterior
- Being tested
- Ganciclovir
- Keywords
- Cytomegalovirus retinopathy, High-dose, Ganciclovir, Intravitreal injection
- Medical subject headings
- Virus Diseases, Uveitis, Posterior, Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanciclovirDrug
Intravitreal Injection of Ganciclovir (IVG) was conducted in a week interval. The initial dose was 6mg/0.1ml at the first injection and it was reduced to 4.5mg/0.1ml at the second time; 3mg/0.1ml of IVG was maintained until the CMV could not be detected in aqueous humor.
| Study group | Role | What they receive |
|---|---|---|
| High dose of ganciclovir group | Experimental | IVG was conducted in a week interval. The initial dose was 6mg/0.1ml at the first injection and it was reduced to 4.5mg/0.1ml at the second time; 3mg/0.1ml of IVG was maintained until the CMV could not be detected in aqueous humor. Receives: Drug: Ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV-DNA load in aqueous humor
The load of CMV-DNA level in aqueous humor was detected by means of real-time polymerase chain reaction (PCR). The aqueous humor was obtained before the IVG.
Measured: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.
Secondary outcomes (2)
Visual function
Best corrected visual acuity (BCVA) measured using a decimal chart
Measured: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.
Occurrence of IVG-related complications
The occurence of IVG-related complications
Measured: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startJan 2014
- Primary completionJan 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infection ViralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wensheng Li, Doctor, Study director, Shanghai Aier Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598452
- Sponsor's protocol ID
- SHIRB2018017
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The accurate CMV-DNA load and its change will be shared in the published paper.
Publications
Jeon S, Lee WK, Lee Y, Lee DG, Lee JW. Risk factors for cytomegalovirus retinitis in patients with cytomegalovirus viremia after hematopoietic stem cell transplantation. Ophthalmology. 2012 Sep;119(9):1892-8. doi: 10.1016/j.ophtha.2012.03.032. Epub 2012 May 30.
PubMed 22657564Kuo IC, Kempen JH, Dunn JP, Vogelsang G, Jabs DA. Clinical characteristics and outcomes of cytomegalovirus retinitis in persons without human immunodeficiency virus infection. Am J Ophthalmol. 2004 Sep;138(3):338-46. doi: 10.1016/j.ajo.2004.04.015.
PubMed 15364214Miao H, Tao Y, Jiang YR, Li XX. Multiple intravitreal injections of ganciclovir for cytomegalovirus retinitis after stem-cell transplantation. Graefes Arch Clin Exp Ophthalmol. 2013 Jul;251(7):1829-33. doi: 10.1007/s00417-013-2368-6. Epub 2013 May 12.
PubMed 23665863Qian Z, Li H, Tao Y, Li W. Initial intravitreal injection of high-dose ganciclovir for cytomegalovirus retinitis in HIV-negative patients. BMC Ophthalmol. 2018 Dec 10;18(1):314. doi: 10.1186/s12886-018-0983-z.
PubMed 30526535
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Non-controlled Trial: Initial Intravitreal Injection of High-dose Ganciclovir for Cytomegalovirus Retinitis in HIV-negative Patients
- ClinicalTrials.gov ID
- NCT03598452
- Acronym / sponsor ID
- SHIRB2018017
- Conditions
- Infection Viral, Uveitis, Posterior
- Keywords
- Cytomegalovirus retinopathy, High-dose, Ganciclovir, Intravitreal injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Jul 2018 (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.
This prospective, non-randomized, non-controlled clinical trial was conducted to examine the clinical outcomes achieved by using initial high-dose intravitreal ganciclovir injections of ganciclovir in treating cytomegalovirus (CMV) retinitis in patients without human immunodeficiency virus (HIV) infection.
Detailed description
Cytomegalovirus retinitis (CMVR) is a serious vision-threatening disease. Intravitreal antiviral drug delivery was used as first-line treatment in several studies when systematic injection has been ruled out. The reported dose of intravitreal injections of ganciclovir (IVG) varied from 200 μg/0.1 ml to 5mg/0.1 ml in patients with AIDS. There was no consensus on the dose of ganciclovir in the treatment of CMVR in HIV-negative patients. Previous work showed the safety and the efficacy of 1mg IVG. The investigators proposed that a higher dose of ganciclovir (6mg/0.1ml) for the first injection followed by lower dose for maintenance may indicate a better result. Therefore, this study was performed to evaluate the therapeutic effect and safety of initial high-dose IVG for CMVR in HIV-negative patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High dose of ganciclovir group | Experimental | Drug: GanciclovirIVG was conducted in a week interval. The initial dose was 6mg/0.1ml at the first injection and it was reduced to 4.5mg/0.1ml at the second time; 3mg/0.1ml of IVG was maintained until the CMV could not be detected in aqueous humor. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with CMVR by ophthalmological examination
- Positive CMV-DNA in aqueous humor approved by real-time PCR.
- HIV-negative.
Key exclusion criteria (3 listed)
- Diabetic retinopathy,
- Glaucoma.
- Optic neuritis.
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 |
|---|---|---|
| GanciclovirIntravitreal Injection of Ganciclovir (IVG) was conducted in a week interval. The initial dose was 6mg/0.1ml at the first injection and it was reduced to 4.5mg/0.1ml at the second time; 3mg/0.1ml of IVG was maintained until the CMV could not be detected in aqueous humor. | Drug | High dose of ganciclovir group |
Primary outcome
CMV-DNA load in aqueous humor
Time frame: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.
The load of CMV-DNA level in aqueous humor was detected by means of real-time polymerase chain reaction (PCR). The aqueous humor was obtained before the IVG.
2 secondary outcomes
Visual function
Time frame: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.
Occurrence of IVG-related complications
Time frame: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 22657564Jeon S, Lee WK, Lee Y, Lee DG, Lee JW. Risk factors for cytomegalovirus retinitis in patients with cytomegalovirus viremia after hematopoietic stem cell transplantation. Ophthalmology. 2012 Sep;119(9):1892-8. doi: 10.1016/j.ophtha.2012.03.032. Epub 2012 May 30.
- Background: PubMed 15364214Kuo IC, Kempen JH, Dunn JP, Vogelsang G, Jabs DA. Clinical characteristics and outcomes of cytomegalovirus retinitis in persons without human immunodeficiency virus infection. Am J Ophthalmol. 2004 Sep;138(3):338-46. doi: 10.1016/j.ajo.2004.04.015.
- Results publication: PubMed 23665863Miao H, Tao Y, Jiang YR, Li XX. Multiple intravitreal injections of ganciclovir for cytomegalovirus retinitis after stem-cell transplantation. Graefes Arch Clin Exp Ophthalmol. 2013 Jul;251(7):1829-33. doi: 10.1007/s00417-013-2368-6. Epub 2013 May 12.
- Derived from this study: PubMed 30526535Qian Z, Li H, Tao Y, Li W. Initial intravitreal injection of high-dose ganciclovir for cytomegalovirus retinitis in HIV-negative patients. BMC Ophthalmol. 2018 Dec 10;18(1):314. doi: 10.1186/s12886-018-0983-z.
- Individual participant dataSharing planned: Undecided. The accurate CMV-DNA load and its change will be shared in the published paper.
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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.
Wensheng Li, Doctor study director
Shanghai Aier Eye Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Ganciclovir in people with Infection Viral and Uveitis, Posterior, run by Aier School of Ophthalmology, Central South University.
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 3 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: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CMV-DNA load in aqueous humor (time frame: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.). 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 NCT03598452, which also lists 4 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 26 Jul 2018.