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The research group has developed new ocular drug delivery technology based on cyclodextrin nanoparticles (NP). The investigators plan to develop and test this technology to help treat diabetic macular edema (DME).
An important step in research was the invention of cyclodextrin nanoparticles, which has just received a US patent. The investigators pre-clinical and clinical work has demonstrated the investigators eye drop suspension with cyclodextrin nano-particles to be superior to conventional eye drops. They increase drug absorbance into the eye and decrease systematic distribution of the drug, hence reducing side effects. Cyclodextrin nanoparticle eye drops deliver drugs to the posterior part of the eye, thus solving one of the biggest obstacles in ocular pharmacology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexamethasone - Cyclodextrin | Experimental |
| |
| Avastin/Laser | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone - Cyclodextrin eye drops | Drug | The study eye will receive the dexamethasone NP eye drops 3 times a day for 3 months. The subject will be handed an eye drop bottle at each monthly visit for self administration of the eye drops. Each eye drop container is to be marked with a date when first opened and discarded after 1 week (unless it contains a preservative). |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity on ETDRS chart | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | 3 months |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Medicine, King Saud University | Riyadh | Riyadh Region | 11411 | Saudi Arabia |
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| intravitreal Avastin injection +/- macular laser | Other | The study eye will receive standard laser and intravitreal injections of Avastin for 3 months. Complete eye examination will be performed prior to drug administration. |
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