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25 patients who are diagnosed with Cytomegalovirus (CMV) anterior segment infection, either uveitis or endotheliitis, will be started on 2% guttae ganciclovir, 1 drop 5 times a day for 6 weeks.
Following 6 weeks of continuous application of 2% guttae ganciclovir, patient will be reviewed at the clinic within 3 hours following the last application of topical ganciclovir and clinical features will be documented for activity assessment. An aqueous sample 0.2ml is drawn. 0.1ml will be sent for RT-PCR for CMV viral load and another 0.1ml will be sent for ganciclovir drug level by HPLC method.
This is non-randomised single armed prospective, cross-sectional, interventional clinical study.
25 patients who are diagnosed with Cytomegalovirus (CMV) anterior segment infection, either uveitis or endotheliitis, at the investigators clinic in Singapore National Eye Centre, who have a positive aqueous real time PCR (RT-PCR) and/or positive tetraplex PCR for CMV and have not had any form of ganciclovir treatment in the past 1 month, will be recruited in the study after taking an informed consent. This will also include the patients who have never been treated with antiviral therapy and those with recurrent disease and have not had any form of ganciclovir treatment for past 1 month.
The clinical features of the active disease will be recorded in the data collection sheet and will include, documentation of the state of the cornea, KPs, AC cells, flare, flare meter reading (where possible), central corneal thickness, Intra ocular pressure (IOP) and C:D ratio.
All patients will be started on 2% guttae ganciclovir, 1 drop 5 times a day.
2% Guttae ganciclovir will be prepared from vials of ganciclovir powder for ganciclovir intravenous infusion using aseptic method.
Following 6 weeks of continuous application of 2% guttae ganciclovir, patient will be reviewed at the clinic within 3 hours following the last application of topical ganciclovir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% guttae Ganciclovir | Experimental | 2% guttae Ganciclovir 5 times a day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% guttae ganciclovir | Drug | 2% guttae ganciclovir 5 times a day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median concentration of ganciclovir in aqueous by HPLC-Mass spectrometry end of week 6 | Ganciclovir concentration in aqueous will be measured by HPLC-Mass spectrometry at the end of week 6 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy in clearing CMV viral load and resolution of anterior uveitis/endotheliitis following 6 weeks of treatment | Clinical efficacy will be measured by resolution of anterior uveitis/ endotheliitis and aqueous tap negative for CMV realtime PCR at the end of week 6 | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SP Chee | Singapre national eye centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore National Eye Centre | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39587428 | Derived | Waduthantri S, Zhou L, Chee SP. Aqueous humour concentration of topically applied 2.0% ganciclovir eye drops in eyes with cytomegalovirus anterior uveitis and endotheliitis. Clin Exp Ophthalmol. 2025 May-Jun;53(4):384-390. doi: 10.1111/ceo.14469. Epub 2024 Nov 25. |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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