NCT03598452

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

4 years

First QC Date

July 4, 2018

Last Update Submit

July 24, 2018

Conditions

Infection ViralUveitis, Posterior

Keywords

Cytomegalovirus retinopathyHigh-doseGanciclovirIntravitreal injection

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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.

Study Arms (1)

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.

Drug: Ganciclovir

Interventions

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.

High dose of ganciclovir group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CMVR by ophthalmological examination
  • Positive CMV-DNA in aqueous humor approved by real-time PCR.
  • HIV-negative.

You may not qualify if:

  • Diabetic retinopathy,
  • Glaucoma.
  • Optic neuritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 22657564BACKGROUND

  • Kuo 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.

    PMID: 15364214BACKGROUND

  • Miao 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.

    PMID: 23665863RESULT

  • Qian 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.

    PMID: 30526535DERIVED

MeSH Terms

Conditions

Virus DiseasesUveitis, PosteriorMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

InfectionsPanuveitisUveitisUveal DiseasesEye DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Wensheng Li, Doctor

    Shanghai Aier Eye Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 26, 2018

Study Start

January 1, 2014

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07