Status:
UNKNOWN
Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
Lead Sponsor:
King Saud University
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01523314
Start Date
March 1 2012
End Date
February 1 2013
Last Update
February 1 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
College of Medicine, King Saud University
Riyadh, Riyadh Region, Saudi Arabia, 11411