Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

NCT ID: NCT01523314

Last Updated: 2012-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-02-28

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 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

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dexamethasone - Cyclodextrin

Group Type: EXPERIMENTAL

dexamethasone - Cyclodextrin eye drops

Intervention Type: 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).

Avastin/Laser

Group Type: ACTIVE_COMPARATOR

intravitreal Avastin injection +/- macular laser

Intervention Type: 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.

Interventions

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).

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abu El-Asrar

Professor, Consultant, Vitreoretinal/Uveitis division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

College of Medicine, King Saud University

Riyadh, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Facility Contacts

Ahmed A Abu El-Asrar, MD, PhD

Role: primary

abuasrar@KSU.EDU.SA

0096614786100 ext. 1430

Marwan A Abouammoh, MD

Role: backup

dr.abouammoh@gmail.com

00966505476426

Other Identifiers

DECEDE

Identifier Type: -

Identifier Source: org_study_id