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Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

NCT01523314 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-02-01

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

dexamethasone - Cyclodextrin eye drops

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).

OTHER

intravitreal Avastin injection +/- macular laser

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.

Sponsors & Collaborators

  • King Saud University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-08-31
Completion
2013-02-28

Countries

  • Saudi Arabia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01523314 on ClinicalTrials.gov