Diabetic Macular EdemaPhase 2/3DECEDENCT01523314
Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
A Phase 2/3 study testing dexamethasone - Cyclodextrin eye drops and intravitreal Avastin injection +/- macular laser in people with Diabetic Macular Edema, run by King Saud University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- dexamethasone - Cyclodextrin eye drops and intravitreal Avastin injection +/- macular laser
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2012to Feb 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Medicine, King Saud University
Riyadh, Riyadh Region, 11411
Ahmed A Abu El-Asrar, MD, PhD, 0096614786100 ext. 1430, abuasrar@KSU.EDU.SA
Marwan A Abouammoh, MD, 00966505476426, dr.abouammoh@gmail.com
About this study
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
- Being tested
- dexamethasone - Cyclodextrin eye drops, intravitreal Avastin injection +/- macular laser
- Keywords
- diabetic macular edema, intravitreal injection, dexamethasone, Cyclodextrin, eye drops, bevacizumab, macular laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone - Cyclodextrin eye dropsDrug
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).
intravitreal Avastin injection +/- macular laserOther
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.
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone - Cyclodextrin | Experimental | Not described Receives: Drug: dexamethasone - Cyclodextrin eye drops |
| Avastin/Laser | Active comparator | Not described Receives: Other: intravitreal Avastin injection +/- macular laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity on ETDRS chart
Measured: 3 months
Secondary outcomes (1)
Intraocular pressure (IOP)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abu El-Asrar, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523314
- Sponsor's protocol ID
- DECEDE
- Acronym
- DECEDE
- Status last verified
- Jan 2012
- First submitted
- 28 Jan 2012
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01523314
- Acronym / sponsor ID
- DECEDE / DECEDE
- Conditions
- Diabetic Macular Edema
- Keywords
- diabetic macular edema, intravitreal injection, dexamethasone, Cyclodextrin, eye drops, bevacizumab, macular laser
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone - Cyclodextrin | Experimental | Drug: dexamethasone - Cyclodextrin eye drops |
| Avastin/Laser | Active comparator | Other: intravitreal Avastin injection +/- macular laser |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone - Cyclodextrin eye dropsThe 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). | Drug | dexamethasone - Cyclodextrin |
| intravitreal Avastin injection +/- macular laserThe study eye will receive standard laser and intravitreal injections of Avastin for 3 months. Complete eye examination will be performed prior to drug administration. | Other | Avastin/Laser |
Primary outcome
Best Corrected Visual Acuity on ETDRS chart
Time frame: 3 months
1 secondary outcome
Intraocular pressure (IOP)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
College of Medicine, King Saud University
Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing dexamethasone - Cyclodextrin eye drops and intravitreal Avastin injection +/- macular laser in people with Diabetic Macular Edema, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity on ETDRS chart (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.