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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganciclovir | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual function | Best corrected visual acuity (BCVA) measured using a decimal chart | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wensheng Li, Doctor | Shanghai Aier Eye Hospital | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22657564 | Background | 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. | |
| 15364214 | Background | 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. |
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The accurate CMV-DNA load and its change will be shared in the published paper.
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D015866 | Uveitis, Posterior |
| D054069 | Multiple Acyl Coenzyme A Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D007239 | Infections |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 |
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| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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|
The occurence 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. |
| 23665863 | Result | 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. |
| 30526535 | Derived | 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. |
| Eye Diseases |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D028361 | Mitochondrial Diseases |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |