Diabetic Macular EdemaNCT03590587
Rapid Structural and Functional Improvements in Following 0.19 mg Fluocinolone Acetonide (FAc) Implant in Diabetic Macular Edema Patients With Poor Visual Acuity: 12-month Audit Results From United Arab Emirates
An observational study of Diabetic Macular Edema, run by Benha University at 1 site in United Arab Emirates.
Trial summary
The Health Authority - Abu Dhabi (HAAD) approved the reimbursement of the slow release FAc implant (ILUVIEN) and it is now available for the treatment of diabetic macular edema (DME) in persons who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- 0.19 mg fluocinolone acetonide (FAc) implant
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 13 Jan 2017to 16 Sep 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Twenty patients with pseudophakic lenses, treated with ILUVIEN, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity [VA; ETDRS letters score], central macular thickness [CMT] and intraocular pressure [IOP]) at baseline, weeks 2-4 and months 3, 6 and 12 months.
Who may be able to join
- DME
- Pseudophakic
Who cannot join
- Other causes of macular edema.
- Phakic
- Know case of gaucoma
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Shiekh Khalifa medical city
Abu Dhabi, 51900
Ahmed Elbarky, 00971557443731 ext. 00971557443731, AHMED.ALBARQY@fmed.bu.edu.eg
tarek elhamaky, MD
About this study
The Health Authority - Abu Dhabi (HAAD) approved the reimbursement of the slow release FAc implant (ILUVIEN) and it is now available for the treatment of diabetic macular edema (DME) in persons who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. We performed a retrospective 12-month audit to assess the efficacy and safety of the FAc implant in our clinical practice.
Read the detailed description
Twenty patients with pseudophakic lenses, treated with ILUVIEN, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity [VA; ETDRS letters score], central macular thickness [CMT] and intraocular pressure [IOP]) at baseline, weeks 2-4 and months 3, 6 and 12 months.
- Conditions
- Diabetic Macular Edema
- Being tested
- 0.19 mg fluocinolone acetonide (FAc) implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.19 mg fluocinolone acetonide (FAc) implantDrug
0.19 mg fluocinolone acetonide (FAc) implant
0.19 mg fluocinolone acetonide (FAc) implantDevice
0.19 mg fluocinolone acetonide (FAc) implant
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients treated with 0.19 mg fluocinolone acetonide (FAc) implant for 12 months Receives: Drug: 0.19 mg fluocinolone acetonide (FAc) implant; Device: 0.19 mg fluocinolone acetonide (FAc) implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
best corrected visual acuity
Measured: 12 months
Secondary outcomes (2)
CMT
Central Macular thickness
Measured: 12 months
IOP
Intraocular pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start13 Jan 2017
- Primary completion15 Sep 2018 (estimated)
- Study completion16 Sep 2018 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheikh Khalifa Medical City
- Responsible party
- Principal investigator, Ahmed Elbarky, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590587
- Sponsor's protocol ID
- skmc
- Status last verified
- Jul 2018
- First submitted
- 7 Jul 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Structural and Functional Improvements in Following 0.19 mg Fluocinolone Acetonide (FAc) Implant in Diabetic Macular Edema Patients With Poor Visual Acuity: 12-month Audit Results From United Arab Emirates
- ClinicalTrials.gov ID
- NCT03590587
- Acronym / sponsor ID
- skmc
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Sheikh Khalifa Medical City
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 15 Sep 2018 (estimated)
- Study completion
- 16 Sep 2018 (estimated)
- First posted
- 18 Jul 2018 (actual)
- 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 Health Authority - Abu Dhabi (HAAD) approved the reimbursement of the slow release FAc implant (ILUVIEN) and it is now available for the treatment of diabetic macular edema (DME) in persons who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. We performed a retrospective 12-month audit to assess the efficacy and safety of the FAc implant in our clinical practice.
Detailed description
Twenty patients with pseudophakic lenses, treated with ILUVIEN, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity [VA; ETDRS letters score], central macular thickness [CMT] and intraocular pressure [IOP]) at baseline, weeks 2-4 and months 3, 6 and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: 0.19 mg fluocinolone acetonide (FAc) implant, Device: 0.19 mg fluocinolone acetonide (FAc) implantpatients treated with 0.19 mg fluocinolone acetonide (FAc) implant for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Twenty patients with pseudophakic lenses, treated with ILUVIEN, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity [VA; ETDRS letters score], central macular thickness [CMT] and intraocular pressure [IOP]) at baseline, weeks 2-4 and months 3, 6 and 12 months.
Key inclusion criteria (2 listed)
- DME
- Pseudophakic
Key exclusion criteria (3 listed)
- Other causes of macular edema.
- Phakic
- Know case of gaucoma
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 |
|---|---|---|
| 0.19 mg fluocinolone acetonide (FAc) implant0.19 mg fluocinolone acetonide (FAc) implant | Drug | 1 |
| 0.19 mg fluocinolone acetonide (FAc) implant0.19 mg fluocinolone acetonide (FAc) implant | Device | 1 |
Primary outcome
BCVA
Time frame: 12 months
best corrected visual acuity
2 secondary outcomes
CMT
Time frame: 12 months
IOP
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Benha University at 1 site in United Arab Emirates.
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 2 inclusion and 3 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 18 Jul 2018. 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 United Arab Emirates. 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.
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?
Contact Ahmed Elbarky, MD (00971557443731 ext. 00971557443731, AHMED.ALBARQY@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: 12 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 18 Jul 2018.