Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

Study Overview
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Brief Summary
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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.

Official Title
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Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: dexamethasone - Cyclodextrin eye drops
* Other: intravitreal Avastin injection +/- macular laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus Pseudophakic in study eye, i.e. with IOL (intra ocular lens) after cataract surgery Diabetic macular edema with central macular thickness over 300 µm on OCT in study eye. If both eyes have DME, then the treatment will be applied to the eye with thicker central macula on OCT. Age 18 years or older Exclusion Criteria: Glaucoma or use of any glaucoma medication Known steroid IOP response Any infectious eye disease Treatment for DME within 6 months, such as laser treatment, intravitreal or subtenon injections of steroids, intravitreal injections of anti vascular endothelelial growth factor medication. Any eye surgery within 3 months or other eye conditions e.g. corneal disorders, ocular hypotony and retinal detachments. Crystalline lens present in study eye Known allergy to cyclodextrins, dexamethasone, ranibizumab or any of the components of the study medications

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexamethasone - Cyclodextrin<br> | Drug: dexamethasone - Cyclodextrin eye drops<br>* 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).<br>|
| Active Comparator: Avastin/Laser<br> | Other: intravitreal Avastin injection +/- macular laser<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity on ETDRS chart |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic macular edema, intravitreal injection, dexamethasone, Cyclodextrin, eye drops, bevacizumab, macular laser