Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis
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|ClinicalTrials.gov Identifier: NCT02943057|
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : October 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Infections||Drug: 2% guttae ganciclovir||Phase 4|
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.
- Clinical features mentioned above will be documented for activity assessment
- Following irrigation of the conjunctival sac with 100ml of N/S to wash out any residual drug, aseptic technique is practised before 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-cameral Penetration and Efficacy of Ganciclovir Following Topical Administration of 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: 2% guttae Ganciclovir
2% guttae Ganciclovir 5 times a day for 6 weeks
Drug: 2% guttae ganciclovir
2% guttae ganciclovir 5 times a day for 6 weeks
- Median concentration of ganciclovir in aqueous by HPLC-Mass spectrometry end of week 6 [ Time Frame: 6 weeks ]Ganciclovir concentration in aqueous will be measured by HPLC-Mass spectrometry at the end of week 6
- Clinical efficacy in clearing CMV viral load and resolution of anterior uveitis/endotheliitis following 6 weeks of treatment [ Time Frame: 6 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943057
|Contact: Samanthila Waduthantriemail@example.com|
|Singapore National Eye Centre||Recruiting|
|Contact: Samanthila Waduthantri firstname.lastname@example.org|
|Study Chair:||SP Chee||Singapre national eye centre|